updated 5/25/17 - harvard university · updated 5/25/17 . curriculum vitae . part i: general...

32
Updated 5/25/17 Curriculum Vitae PART I: General Information Name: David Alan Schoenfeld Office Address: Massachusetts General Hospital Biostatistics Center 50 Staniford St., Suite 560 Boston, MA 02114 Home Address: 41 Brook Road, Sharon, MA 02067 E: Mail: [email protected] FAX: 617-724-9878 Citizenship: U.S. Citizen Education: 1967 B.A. Reed College, Portland, Oregon 1968 M.A. University of Oregon, Eugene, Oregon (mathematics) 1974 Ph.D. University of Oregon, Eugene, Oregon (mathematics/statistics) Postdoctoral Training: 1974-1975 Stanford University Medical School, Stanford, CA Academic Appointments: 1975-1977 Research Assistant Professor, State University of New York at Buffalo 1977-1981 Assistant Professor, Dept. of Biostatistics, Harvard School of Public Health, Boston, MA 1981-1999 Associate Professor, Dept. of Biostatistics, Harvard School of Public Health Boston, MA 1985-1998 Associate Professor of Biostatistics, Dept. of Medicine, Harvard Medical School, Boston, MA 1998- Professor of Medicine, Harvard Medical School, Boston, MA 1999- Professor in the Department of Biostatistics, Harvard School of Public Health, Boston, MA Hospital or Affiliated Institution Appointments:

Upload: others

Post on 21-May-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Updated 5/25/17

Curriculum Vitae PART I: General Information Name: David Alan Schoenfeld Office Address: Massachusetts General Hospital Biostatistics Center 50 Staniford St., Suite 560 Boston, MA 02114 Home Address: 41 Brook Road, Sharon, MA 02067 E: Mail: [email protected] FAX: 617-724-9878 Citizenship: U.S. Citizen Education: 1967 B.A. Reed College, Portland, Oregon 1968 M.A. University of Oregon, Eugene, Oregon (mathematics) 1974 Ph.D. University of Oregon, Eugene, Oregon (mathematics/statistics) Postdoctoral Training: 1974-1975 Stanford University Medical School, Stanford, CA Academic Appointments: 1975-1977 Research Assistant Professor, State University of New York at Buffalo

1977-1981 Assistant Professor, Dept. of Biostatistics, Harvard School of Public Health, Boston, MA

1981-1999 Associate Professor, Dept. of Biostatistics, Harvard School of Public Health Boston, MA

1985-1998 Associate Professor of Biostatistics, Dept. of Medicine, Harvard Medical School, Boston, MA

1998- Professor of Medicine, Harvard Medical School, Boston, MA 1999- Professor in the Department of Biostatistics, Harvard School of Public Health,

Boston, MA

Hospital or Affiliated Institution Appointments:

Schoenfeld, David A., Ph.D. (continued)

2

1977-1981 Assistant Scientist, Dana-Farber Cancer Institute, Boston, MA 1981-1986 Associate Professor of Biostatistics, Dana-Farber Cancer Institute, Boston, MA

1984-2007 Associate Biostatistician, Massachusetts General Hospital, Boston, MA 1985- 2008 Director, Biostatistics Center, Massachusetts General Hospital, Boston, MA

2007- Biostatistician, Massachusetts General Hospital, Boston, MA Other Professional Positions and Major Appointments: 1971-1972 Computer Programmer, Computer Service, University of Oregon Medical

School, Portland, Oregon. Major Committee Assignments: International:

1983-1984 Consultant to the World Health Organization on Cancer Control in Latin America

1984 World Health Organization Consultant on Biostatistics Breast Cancer Screening Project, Leningrad, USSR

1984 World Health Organization, Consultant to the Expert Committee on Cancer Pain, Geneva, Switzerland

2006- National Institute of Health, Division of AIDS, ASIA DSMB: Data and Safety Monitoring Board for Clinical Trials in Asia

2012- Referee Panel for Health and Medical Research Fund (HMRF), Hong Kong, SAR China.

National: 1975-1987 Eastern Cooperative Oncology Group, Head and Neck Committee 1975-1986 Eastern Cooperative Oncology Group, Melanoma Committee 1975-1982 Radiation Therapy Oncology Group, Brain Committee

1980-1982 Neutron-Pion Radiotherapy Study Group, Executive Committee (group statistician)

1980-1982 Radiation Therapy Oncology Group, Executive Committee (coordinating statistician)

1980-1982 Radiation Therapy Oncology Group, Cancer Control Committee 1980-1982 National Pancreatic Cancer Project, Grant Review Committee, National Cancer

Institute 1984-1988 Scientific Advisory Panel of the Love Canal Technical Review Committee

Environmental Protection Agency 1994 Steering Committee of Adult Respiratory Distress Syndrome Clinical Network 1998-1999 Informatics Technology Group Steering Committee of the Cancer Genetics

Network (Chairman) 2000 University of Pennsylvania Specialized Center of Research (SCOR) in Acute

Lung Injury External Advisory Board 2004 Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee

Regional:

Schoenfeld, David A., Ph.D. (continued)

3

1977-1983 Institutional Review Board - Human Subjects Committee, Harvard Community Health Plan.

Harvard School of Public Health 1977-1979 Curriculum Committee, Department of Biostatistics 1979-1981 Doctoral Examination Committee (Chairman), Department of Biostatistics 1981-1983 Degree Program Committee (Chairman), Department of Biostatistics

1981-1984 Committee on Admissions and Degrees, (Chairman-Masters Subcommittee) 1988-1997 Statistical Center for the AIDS Clinical Trials Group?

1994-1997 Lefkopoulou Memorial Lecture Committee (Chairman, 1994), Department of Biostatistics

1998-1999 Masters Committee 1999-2000 Practical Training Committee

2000-2001 Admissions Committee 2001-2002 Seminar Committee

Massachusetts General Hospital 1984- Scientific Advisory Committee, Mallinckrodt General Clinical Research Center 1993-1995 Massachusetts General Hospital Task Force on Clinical Research, Subcommittee on Research Infrastructure Professional Societies:

1973- Institute of Mathematical Statistics, (Member) 1974- American Statistical Association, (Member) 1974- Biometric Society, (Member) 1991- International Statistical Institute, (Member) 1994- Association of GCRC Statisticians, (President 1996)

2000-2002 Committee of Presidents of Statistical Societies Award Committee (Chair 2000) Editorial Boards: 1976- Communications in Statistics, Biometrics, Journal of the American Statistical

Association, Annals of Statistics, Cancer Clinical Trials, Cancer Treatment Reports, Association for Testing and Materials, New England Journal of Medicine,

Hypertension, Statistics in Medicine, Controlled Clinical Trials, (Ad Hoc Reviewer)

1997 Controlled Clinical Trials, (Associate Editor)

Schoenfeld, David A., Ph.D. (continued)

4

Awards and Honors: 1991 Elected Member of International Statistical Institute 1992 Elected Fellow of the American Statistical Association Major Research Interests:

Survival Theory Isotonic Regression Carcinogenesis bioassay and low dose extrapolation The development of statistical methods for biomedical research Statistical Computing PART II: Research, Teaching, and Clinical Contributions A: Narrative report of Research, Teaching, and Clinical Contributions.

I provide statistical support to the Mallinckrodt Clinical Research Center, the Clinical Nutrition Research Center, the program project on Heart Transplantation, the Burn Trauma Center, the Neurology Clinical Trials Unit and the Schizophrenia Research Center at Massachusetts General Hospital. In 1994 I was awarded a contract to establish a Coordinating Center for a Clinical Network for the Treatment of Acute Respiratory Distress Syndrome (ARDS). The coordinating center is responsible for the statistical design, data analysis, computing, data management and logistical support of a series of trials of ARDS therapies. Building on the success of this project, I helped Dr. Finkelstein apply for a grant to establish a Coordinating Center for Cancer Genetics Network, which was awarded in 1998. I have made major contributions as a collaborator with medical investigators in Oncology, Endocrinology and Cardiology as well as numerous other fields. In 1984, my work in Head and Neck Cancer was recognized by The International Conference, where I was a keynote speaker. I was instrumental in the design and analysis of the multicenter Fish Oil Restenosis Trial. I have conducted important research in statistical methodology. I developed the first omnibus goodness of fit test for the proportional hazard model. I developed the so-called ``Schoenfeld Residuals,'' which are included in major statistical software packages including SAS. I developed sample size and efficiency formulae for the commonly used nonparametric tests for comparing survival distributions and later extended these results to the case where the proportional hazard model is used to correct for covariates. I developed a widely used nomogram for finding the sample size of survival studies and wrote papers on the design of studies in Cancer and AIDS. I derived confidence intervals for a dose response curve, which takes into account that such curves are either non-increasing or non-decreasing. Dr. Dianne Finkelstein and I developed a new method of analyzing animal experiments for testing whether compounds are carcinogens that combine data from the pathological examination of different tissues. Dr. David Byar and I led a group of prominent statisticians working on AIDS research to write a position paper, published in the New England Journal of Medicine, on how clinical research in AIDS should be organized and conducted. My paper on Phase II trials, which was presented as an invited talk at the International AIDS meeting has set the standard for these trials. Dr. Finkelstein and I edited the first book to be published on statistical methods in AIDS clinical trials.

Schoenfeld, David A., Ph.D. (continued)

5

My current research includes methods for combining endpoints in clinical trials; methods for clinical trials in ARDS and methods for analyzing interval censored data. In 1997 I was awarded an RO1 to conduct research on methods for analyzing genetic case control studies. I developed a WEB site to help investigators determine sample sizes for clinical trials. I have taught courses at the Harvard School of Public Health on Data Analysis, Statistical Inference and Regression Analysis and I have had three Ph.D. students. I provide internship opportunities for students at the Harvard School of Public Health. I teach a yearly short course in statistics for clinical investigators and post-doctoral fellows at the Massachusetts General Hospital.

B: Funding Information 1979-1982 NCI PI Young Investigator Research Grant 1982- 1984 NIEHS Co-PI Alternative Designs of Standard Cancer Bioassay 1982-1984 Mellon Foundation PI Faculty Development Award 1986-1988 NIEHS PI Non Parametric Bioassay Techniques for Environmental Health Research 1995-2013 NHLBI PI Coordinating Center for a Clinical Network for the Treatment of Adult Respiratory Distress Syndrome 1997 NIGMS PI Statistical Methods for Genetic Case Control Studies 2009-2014 NHLBI PI Rule-Out Myocardial Infarction Using

Computed Assisted Tomography –ROMICAT II, DCC

2014- NHLBI PI Clinical Coordinating Center for a NHLBI

Prevention and Early Treatment of Acute Lung Injury (PETAL) Network

C. Report of Current Research Activities Project: ARDS Clinical Network (3 National Clinical Trials) Role: Group Statistician and Principal Investigator of the Clinical Coordinating Center Project: Clinical Trial of Ceftriaxone in ALS Role: Statistician

Schoenfeld, David A., Ph.D. (continued)

6

Project: Harvard Clinical and Transitional Science Center Role: Statistician Project: Hormonal Factors in the Treatment of Anorexia Nervosa Role: Statistician Project: Tolerance - An Approach To Cardiac Allo & Xenotransplants Role: Statistician Project: Rule-Out Myocardial Infarction Using Computed Assisted Tomograpy –ROMICAT

II Role: Principal Investigator Statistician D. Report of Teaching

Harvard School of Public Health 1979-1981 Data Analysis BIO 251a,b, Co-developed course, 50 students, 30 hours 1979-1981 Statistical Inference, BIO 218c,d, Developer and Lecturer, 5 students, 100 hours 1986-1988 Regression and Analysis of Variance, BIO 263a,b, BIO 235a, b, Co-developed

course 20 students, 50 hours Massachusetts General Hospital

1985-2001 Biostatistics for Clinical Investigators, 10-20 post-doc fellows and faculty, 3-6 hours

1997-2000 Biostatistics for Laboratory Investigators, 3-6 hours 2001-2002 Working with a Biostatistician, 12-30 post-doc fellows and faculty, 2 hours Continuing Medical Education Courses 1982 Statistical Planning and Analysis for Clinical Trials, CME lecturer, 150 students,

2 hours Trainees

1988 Roger Davis, Ph.D., Thesis Advisor 1988 Donna Neuberg, Ph.D., Thesis Advisor 1990 Kathleen Propert, Sc.D. 1995 Amrik Shah, Ph.D., Thesis Advisor

1996- 1997 Xiolin Wang, Traineeship at Massachusetts General Hospital 1997 William Goggins, Sc.D., Co-Thesis Advisor with Dianne Finkelstein

2000 David Loecke, Summer Internship 2001 David Andorsky - Fourth year – Medical Student Basic Science Rotation 2006 Natasa Rajicic, Ph.D., Co-Thesis Advisor with Dianne Finkelstein 2012 Jessie Hsu, Co-Thesis Advisor with Dianne Finkelstein 2012 Ritesh Ramchandani, Co-Thesis Advisor with Dianne Finkelstein 2012 Dustin Rabideau, MA student

Schoenfeld, David A., Ph.D. (continued)

7

2013 Erin McDonnell, MA student 2014 Avery Yuan, MA student 2014 Jing Zhao, MA student 2015 Haiyue Zhang, MA Student

Selected Regional, National or International Contributions

1981 Logistic Models-Summer Conference on Statistics in Cancer Research, New

York, 1981 1984 Statistical Methods for Cancer Control, University of Chile, Santiago de Chile

(Short Course Director and Lecturer) 50 students, 3-hour lecture, total course 20 hours.

1984 An Estimate of the Survival Benefit of Chemotherapy for Advanced Head and Neck Cancer and its Implications to the Design of Clinical Trials. Keynote speech International Conference on Head and Neck Cancer July 22-27, 1984.

1984 Regression Methods for Laboratory and Clinical Experiments “Animal Experiments and Clinical Trials”. First Midyear Topical Symposium “Multiple Regression Analysis: Applications in the Health Sciences” March 12-16, 1984.

1991 CD4 and DC8 lymphocytes as surrogate endpoints for anti-retroviral efficacy. International Conference on AIDS San Francisco, 1991.

1991 Surrogate Markers: Concepts, Results, Implications: (with Jean Marie Anduino, Victor DeGruttola, Stephen Lagakos, Dan U. Lin, Laurel Smith, Anastasios Tsiatis, Michael Wolfsohn) Measurement and Analysis Issues for Quality of Life Outcomes of Clinical Trials in the ACTG (with Marcia A. Testa) International Statistical Institute, Cairo Egypt, 1991.

1998 Combining Endpoints in Clinical Trials with Application to Trials in Acute Respiratory Distress Syndrome. Biometrics Society Eastern North American Region, Pittsburgh, March 1998.

2000 An algorithm for calculating the power of the Logistic and Proportional Hazard Models. International Biometrics Society, Berkley, California, July 2000.

2002 An estimate for treatment comparisons among survivors in randomized trials. International Biometrics Society, Frieburg, Germany, August 2002

2010 Biostatistics Meets Psychiatry, North Shore Hospital, New York 2010 Design of ALS Clinical Trials, Harvard School of Pubic Health, Boston,

Massachusetts 2010 Revisiting Miss-classified Proportional Hazards Models, Greece 2010 Analyzing ALSFRS as a Primary Outcome Measure, Berlin, Germany 2011 Statistical Design of ARDS Clinical Trials, American Thoracic Society, Denver,

Colorado PART III: Bibliography Original Articles: 1. Schoenfeld D. Asymptotic properties of tests based on linear combinations of the orthogonal

components of the Cramer-von Mises statistic. Ann Stat. 1977; 1:1017-1026. 2. Costanza M, Nathanson L, Schoenfeld D, Wolter J, Colsky J, Regelson W, Cunningham T,

Sedransk N. Results with Methyl-CCNU and DTIC in metastatic melanoma. Cancer. 1977; 40:1010-1015.

Schoenfeld, David A., Ph.D. (continued)

8

3. Nathanson L. Schoenfeld D. Regelson W. Colsky J. Mittelman A. Prospective comparison of intralesional and multipuncture BCG in recurrent intradermal melanoma. Cancer. 1979 May; 43(5):1630-5.

4. Schoenfeld D. Determining the number of patients necessary to test a combination of treatments. Can Clin Trials. 1979; 2:155-156.

5. Schoenfeld D, Gelber R. Designing and analyzing clinical trials, which allow institutions to randomize patients to a subset of the treatments under study. Biometrics. 1979; 35:825-830.

6. Schoenfeld D. Statistical considerations for pilot studies. Int J Rad Oncol Biol Phys. 1980; 6:371-374.

7. Schoenfeld D. Tests based on linear combinations of the orthogonal components of the Cramer-von Mises statistic when parameters are estimated. Ann Stat. 1980; 8:1017-1022.

8. Schoenfeld D, Kallman R. Determining the labeling index in autoradiography. Cell and Tissue Kinetics. 1980; 13:339-347.

9. Cohen M, Schoenfeld D, Wolter J. Randomized trial of Chlorpromazine, Caffeine, and Methyl-CCNU in disseminated melanoma. Can Treat Rep. 1980; 64:151-154.

10. Schoenfeld D. Chi-squared goodness of fit tests for the proportional hazard regression model. Biometrika. 1980; 67:145-153.

11. DeConti RC, Schoenfeld D. A randomized prospective comparison of intermittent methotrexate, methotrexate with leucovorin and a methotrexate combination in head and neck cancer. Cancer. 1981; 48:1061-1072.

12. Schoenfeld D. The asymptotic properties of non-parametric tests for comparing survival distributions. Biometrika. 1981; 68:316-319.

13. Schoenfeld D, Richter J. Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics. 1982; 38:163-170.

14. Vogl S, Lerner H, Kaplan B, Camacho F, Cinberg J, Schoenfeld D. Mitomycin-C, methotrexate, bleomycin and cis-diamminedichloroplatinum II in the chemotherapy of advanced squamous cancer of the head and neck. Cancer. 1982; 50:6-9.

15. Vogl SE, Schoenfeld D, Kaplan BH, Lerner HJ, Horton J, Paul AR, Barnes LE. Methotrexate alone or with regional subcutaneous corynebacterium parvum in the treatment of recurrent and metastatic squamous cancer of the head and neck. Cancer. 1982; 50:2295-2300.

16. Schoenfeld D, Rosenbaum C, Horton J, Wolter J, Falkson G, DeConti R. A comparison of adriamycin versus vincristine, adriamycin, and cyclophosphamide versus vincristine, actinomycin-D, and cyclophosphamide for advanced sarcoma. Cancer. 1982; 50:2757-2762.

17. Schoenfeld D. Partial residuals for the proportional hazards regression model. Biometrika. 1982; 69:239-241.

18. Nelson DF, Schoenfeld D, Weinstein A, Nelson JS, Wasserman T, Goodman RL, Carabell S. A randomized comparison of misonidazole sensitized radiotherapy plus BCNU and radiotherapy plus BCNU for treatment of malignant glioma after surgery, preliminary results of an RTOG study. Int J Rad Oncol Biol Phys. 1983; 9:1143-1152.

19. Lerner H, Marcovitz E, Schoenfeld D, Zaren H. Second malignancies diagnosed in patients receiving chemotherapy at the Pennsylvania Hospital. J Surg Oncol. 1983; 23:195-197.

20. Schoenfeld D. Sample size formulae for the proportional hazards regression model. Biometrics. 1983; 39:499-503.

21. Nelson JS, Tsukada Y, Schoenfeld D, Fulling K, Lamarche J, Peress N. Necrosis as a prognostic criterion in malignant, supratentorial, astrocytic gliomas. Cancer. 1983; 52:550-554.

22. Chang CH, Horton J, Schoenfeld D, Salazer O, Perez-Tamayo R, Kramer S, Weinstein A, Nelson JS, Tsukada Y. Comparison of postoperative radiotherapy and combined postoperative radiotherapy and chemotherapy in the multidisciplinary management of malignant gliomas. Cancer. 1983; 52:997-1007.

23. Lerner H, Schoenfeld D, Martin A, Falkson G, Borden E. Malignant mesothelioma: The eastern cooperative oncology group experience. Cancer. 1983; 52:1981-1985.

24. Lagakos SW, Schoenfeld DA. Properties of proportional-hazards score tests under misspecified regression models. Biometrics. 1984; 40:1037-1048.

Schoenfeld, David A., Ph.D. (continued)

9

25. Shimaoka K, Schoenfeld D, DeWys W, Creech R, DeConti R. A randomized trial of doxorubicin versus doxorubicin plus cisplatin in patients with advanced thyroid carcinoma. Cancer. 1985; 9:2155-60.

26. Vogl SE, Schoenfeld DA, Kaplan BH, Lerner HJ, Creech RH, Horton J. A randomized prospective comparison of methotrexate with a combination of methotrexate, bleomycin and cisplatinum in head and neck cancer. Cancer. 1985; 56:432-42.

27. Arseneau J, Schoenfeld D, Borden E. A phase II study of dihydroxyanthracenedione (DHAD, Mitoxantrone, NSC 301739) in advanced malignant melanoma. Investigational New Drugs. 1986; 4:53-56.

28. Maor M, Schoenfeld D, Davis L. Evaluation of a neutron boost in head and neck cancer. Am J Clin Oncol. 1986; 9:62-66.

29. Nelson FN, Diener-West M, Weinstein AS, Schoenfeld D, Nelson JS, Sause WT, Chang CH, Goodman R, Carabell S. A randomized comparison of misonidazole sensitized radiotherapy plus BCNU for treatment of malignant glioma after surgery: Final report of an RTOG study, Int J Rad Oncol Biol Phys. 1986; 12:1793-1800.

30. Dimsdale JE, Pierce C, Schoenfeld D, Brown A, Zusman R, Graham R. Suppressed anger and blood pressure: The effects of race, sex, social class, obesity, and age. Psychosom Med. 1986; 48:430-436

31. Greenspan SL, Klibanski A, Schoenfeld DA, and Ridgway EC. Pulsatile secretion of thyrotropin in man. J Clin Endocrin Metab. 1986; 63: 661-668.

32. Schoenfeld D. Confidence bounds for normal means under order restriction, with applications to toxicology experiments and low dose extrapolation. J Amer Stat Assoc. 1986; 81:186-95.

33. Eagle KA, Mulley AG, Singer DE, Schoenfeld DA, Harthorne JW, Thibault GE. Single chamber and dual chamber cardiac pacemakers: a formal cost comparison. Ann Intern Med. 1986; 105:264-271.

34. Tompkins GT, Burke JF, Schoenfeld DA, Contrado CB, Quinby CQ Jr., Behringer GC, Ackroyd FW. Prompt eschar excision: A treatment system contributing to reduced burn mortality-a statistical evaluation of burn care at the Massachusetts General Hospital (1974-1984). Ann Surg. 1986; 204:272-281.

35. Lagakos SW and Schoenfeld DA. Omitting covariates from the proportional hazards model. Biometrics. 1986; 42: 995-995

36. Peters WP, Eder JP, Henner WD, Schryber S, Wilmore D, Finberg R, Schoenfeld D, Bast R, Gargone B, Antman K, Anderson J, Anderson K, Kruskall MS, Schnipper L, and Frei III. High dose combination alkylating agents with autologous bone marrow support: A phase one trial. J Clin Oncol. 1987; 4:646-654

37. Ervin TJ, Clark JR, Weichselbaum RR, Fallon BG, Miller D, Fabian RL, Posner MR, Norris CM Jr, Tuttle SA, Schoenfeld DA, et al. An analysis of induction and adjuvant chemotherapy in the multidisciplinary treatment of squamous-cell carcinoma of the head and neck. J Clin Oncol. 1987; 5:10-20.

38. Schoenfeld, DA, Tsiatis AA. A modified logrank test for highly stratified data. Biometrika. 1987; 74:167-175.

39. Klibanski A, Biller BMK, Rosenthal DI, Schoenfeld DA, Saxie V. Effects of prolactin and estrogen deficiency in amenorrheic bone loss. J Clin Endocrin Metab. 1988; 67: 124-130.

40. Hall JE, Brodie TD, Badger TM, Rivier J, Vale W, Conn PM, Schoenfeld D, Crowley WF Jr. Evidence of differential control of FSH and LH secretion by gonadotropin-releasing hormone (GnRH) from the use of a GnRH antagonist. J Clin Endocrin Metab. 1988; 67: 524-531.

41. Kelly TL, Slovik DM, Schoenfeld DA, Neer RM. Quantitative digital radiography versus dual photon absorptiometry of the lumbar spine. J Clin Endocrin Metab. 1988; 67: 839-844.

42. Greenberg BM, Masem M, Ragozzino M, Schoenfeld D, May JW Jr. The role of magnetic resonance imaging in assessing elevated intracompartmental pressure in the rabbit hind limb. Plast Reconstr Surg. 1988; 82:678-87.

Schoenfeld, David A., Ph.D. (continued)

10

43. Mann DL, Foale RA, Gillam LD, Schoenfeld D, Newell J, Weyman AE. Early natural history of regional left ventricular dysfunction following experimental myocardial infarction. Amer Heart J. 1988; 115:538-546.

44. Shea TC, Antman KH, Eder JP, Elias A, Peters WP, Shryber S, Henner WD, Schoenfeld DA, Schnipper LE, Frei III. Malignant melanoma, treatment with high-dose combination alkylating agent chemotherapy and autologous bone marrow support. Arch Dermatol. 1988; 124: 878-884.

45. Tompkins RG, Remensnyder JP, Burke JF, Tompkins DM, Hilton JF, Schoenfeld DA, Behringer GE, Bondoc CC, Briggs SE, Quinby WC. Significant reductions in mortality for children with burn injuries using prompt eschar excision. Ann Surg. 1988; 208:33-41.

46. Spratt DI, O'Dea LSL, Schoenfeld D, Butler J, Rao PN, Crowley WF Jr. Neuroendocrine-gonadal axis in normal men: Frequent sampling of LH, FSH, and testosterone, Amer J Physiol: Endocrin Metab. 1988; 254:E658-E666.

47. Green SB, Ellenberg SS, Finkelstein D, Forsythe AB, Freedman LS, Freeman K, Lefkopoulou M, Schoenfeld D, and Smith P. Issues in the design of drug trials for AIDS. Controlled Clinical Trials. 1989; 11:80-87.

48. Alavi JB, Schoenfeld D, Skeel RT, Kirkwood R, Tsung L, Marsh JC. Phase II trial of spirogermanium and vindesine in malignant glioma. Am J Clin Oncol. 1989; 12:8-10

49. Tompkins RG, Hilton JF, Burke JF, Schoenfeld DA, Hegarty MT, Bondoc CC, Quinby WC Jr., Behringer GE, Ackroyd FW. Increased survival after massive thermal injuries in adults: preliminary report using artificial skin. Crit Care Med. 1989; 17:734-740-50.

50. Rubin RH, Lynch P, Pasternack MS, Schoenfeld D, Medearis DN Jr. Combined antibody and ganciclovir treatment of murine cytomegalovirus-infected normal and immunosuppressed BALB/c mice. Antimicrobial Agents and Chemotherapy. 1989; 33:1975-1979.

51. Finkelstein DM, Schoenfeld DA. Analysis of multiple tumor data from a rodent Carcinogenicity experiment. Biometrics. 1989; 45:219-230

52. Finkelstein JS, Spratt DI, O’Dea LS, Whitcomb RW, Klibanski A, Schoenfeld DA, Crowley WF Jr. Pulsatile gonadotropin secretion after discontinuation of long term gonadotropin-releasing hormone (GnRH) administration in a subset of GnRH-deficient men. J Clin Endocrin Metab. 1989; 69:377-385.

53. Oppenheim DS, Greenspan SL, Zervas NT, Schoenfeld DA, Klibanski A. Elevated serum lipids in hypogonadal men with and without hyperprolactinemia. Ann Intern Med. 1989; 111:288-292.

54. O'Dea LS, Finkelstein JS, Schoenfeld DA, Butler JP, Crowley WF Jr. Interpulse interval of GnRH stimulation independently modulates LH secretion. Am J Physiol. 1989; 256:E510-549.

55. Gelenberg AJ, Wojcik JD, Falk WE, Baldessarini RJ, Zeisel SH, Schoenfeld D, Mok GS. Tyrosine for depression: a double-blind trial. J Affective Dis. 1990; 19:125-132.

56. Landy H, Boepple PA, Mansfield MJ, Charpie P, Schoenfeld D, Link K, Romero G, Crawford JD, Crigler JF Jr., Blizzard RM, Crowley WF Jr. Sleep modulation of neuroendocrine function: developmental changes in gonadotropin-releasing hormone secretion during sexual maturation. Pediatr-Res. 1990; 28:213-217.

57. Zurawski VR Jr., Sjovall K, Schoenfeld DA, Broderick SF, Hall P, Bast RC, Eklund G, Mattsson B, Connor RJ, Prorock PC, Knapp RC, Einhorn N. Prospective evaluation of serum CA 125 levels in a normal population, Phase I: The specificities of single and serial determinations in testing for ovarian cancer. Gyn Oncol. 1990; 36: 299-305.

58. Collier AC, Bozzette S, Coombs RW, Causey DM, Schoenfeld DA, Spector SA, Pettinelli CB, Davies G, Richman DD, Leedom JM, Kidd P, Corey L. A pilot study of low-dose zidovudine in human immunodeficiency virus infection. N Engl J Med. 1990; 323:1015-1021.

59. Byar DP, Schoenfeld DA, Green SB, Amato DA, Anderson JR, Collins R, Davis R, De Gruttola V, Ellenberg SS, Finkelstein DM, Freedman LS, Gail M, Gatsonis C, Gelber RD, Lagakos S, Lefkopoulou M, Peto J, Peto R, Peto T, Simon R, Tsiatis AA, Zelen M. Design considerations for AIDS trials. N Engl J Med. 1990; 323:1343-1348.

60. Mitlak BH, Daly M, Potts JT Jr., Schoenfeld D, Neer M. Asymptomatic primary hyperparathyroidism. J Bone Mineral Res. 1991; 6:S103-S111.

Schoenfeld, David A., Ph.D. (continued)

11

61. Growdon JH, Nader TM, Schoenfeld J, Wurtman RJ. L-threonine in the treatment of spasticity. Clin Neuropharmacol. 1991 Oct;14(5):403-12.

62. Faustman D, Schoenfeld D, Ziegler R. T-Lymphocyte changes linked to autoantibodies association of insulin autoantibodies with CD4+CD45R+ lymphocyte subpopulation in prediabetic subjects. Diabetes. 1991; 40:590-597.

63. Ghika J, Tennis M, Hoffman E, Schoenfeld D, Growdon J. Idazoxan treatment in progressive supranuclear palsy. Neurology. 1991; 41:986-991.

64. Finkelstein JS, Whitcomb RW, 0'Dea LSL, Longscope C, Schoenfeld DA, Crowley WJ Jr. Sex steroid control of gonadotropin secretion in the human male, effects of testosterone administration in normal and GnRH-deficient men. J Clin Endocrin Metab. 1991; 73:609-620.

65. Biller MK, Coughlin JF, Saxe V, Schoenfeld D, Sprat DI, Kilbanski A. Osteopenia in women with hypothalamic amenorrhea: A prospective study. Obstet Gynecol. 1991; 78:996-1001.

66. Hauser SL, Doolittle TH, Lopez-Bresnahan M, Shahani B, Schoenfeld D, Shih V, Growdon JH and Lehrick JR. An antispasticity effect of L-threonine in multiple sclerosis. Arch Neurol. 1992; 49:923-926.

67. Hall JE, Schoenfeld DA, Martin KA, Crowley WF Jr. Hypothalamic gonadotropin-releasing hormone secretion and follicle-stimulating hormone dynamics during the luteal-follicular transition. Clin Endocrin Metab. 1992; 74:600-607.

68. Jay N, Mansfield MJ, Blizzard RM, Crowley WF Jr, Schoenfeld D, Rubin L, Boepple PA. Ovulation and menstrual function of adolescent girls with central precocious puberty after therapy with gonadotropin-releasing hormone agonists. J Clin Endocrin Metab. 1992; 75:890-894.

69. Katznelson L, Oppenheim D, Coughlin JF, Kliman B, Schoenfeld DA, and Klibanski A. Chronic somatostatin analog administration in patients with alpha-subunit secreting pituitary tumors. J Clin Endocrin Metab. 1992; 75:1318-1325.

70. Von Deimling A, Louis DN, von Ammon K, Petersen I, Hoell T, Chung RY, Martuza RL, Schoenfeld DA, Yasargil MG, Wiestler OD, Seizinger, BR. Association of epidermal growth factor receptor gene amplification with the loss of chromosome 10 in human glioblastoma multiforme. J Neurosurg. 1992; 77:295-301.

71. Gibas A, Blewett DR, Schoenfeld DA and Dienstag JL. Prevalence and incidence of viral hepatitis in health workers in the prehepatitis B vaccination era. Am J Epidem. 1992; 136:603-610.

72. Armstrong JA, McMahon D, Xioa-Li-Huang, Pazin GJ, Phalguni G, Rinaldo CR Jr. Schoenfeld DA, Gaccione P, Tripoli CA, Bensasi S, Ho M. A phase I study of ampligen in human immunodeficiency virus-infected subjects. J Infect Dis. 1992; 166:717-722.

73. Von Deimling A, von Ammon K, Schoenfeld D, Wiestler OD, Seizinger BR, Louis DN. Subsets of glioblastoma multiforme defined by molecular genetic analysis Brain Pathology 1993; 3:19-26.

74. Schoenfeld DA, Finkelstein DM, Richman DD. Designing phase II studies of chemotherapy for HIV infection using CD4 as an end-point. AIDS. 1993; 7:955-958.

75. Lin DY, Fischl MA, Schoenfeld DA. Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials. Stat Med. 1993; 12:835-842

76. Ushuku K, Joshi N, Narendra J, Hatem CH Jr., Alper CA, Schoenfeld DA, Hauser, SL. The human T-cell receptor beta-chain repertoire: longitudinal fluctuations and assessment in MHC matched populations. Immuno-genetics. 1993; 38:193-198.

77. Finkelstein DM, Moore DF, Schoenfeld, DA. A proportional hazards model for truncated AIDS data. Biometrics. 1993; 49:731-740.

78. Trippel SP, Wrobelwski J, Makower A, Whelan MC, Schoenfeld D, Doctrow SR. Regulation of growth-plate chondrocytes by insulin-like growth-factor I and basic fibroblast growth factor. J Bone Joint Surg. 1993;75:177-189

79. Brown AR, Gelberman RH, Seiler JG, Abrahamsson S, Weiland AJ, Urbaniak JR, Schoenfeld DA, Furcolo D. Carpal tunnel release, a prospective, randomized assessment of open and endoscopic method. J Bone Joint Surg. 1993; 75-A: 1265-1275.

80. Mitlak BH, Schoenfeld D, Neer RM. Accuracy, precision, and utility of spine and whole-skeleton mineral measurements by DXA in rats. J Bone Mineral Metab. 1994; 9:119-126.

Schoenfeld, David A., Ph.D. (continued)

12

81. Finkelstein DM, Schoenfeld DA. Analysing survival in the presence of a variable. Stat Med. 1994; 13:1747-1754.

82. Axelrod L, Camuso J, Williams E, Kleinman K, Briones E, Schoenfeld D. Effects of a small quantity of omega-3 fatty acids on cardiovascular risk factors in NIDDM. A randomized, prospective, double-blind, controlled study. Diabetes Care. 1994; 17:37-44.

83. Zusman RM, Hui KY, Nussberger J, Christensen DM, Higgins J, Carlson WD, Schoenfeld D, Haber E. R- PEP-27, a potent renin inhibitor, decreases plasma angiotensin II and blood pressure in normal volunteers. Am J Hypertension. 1994; 74:295-301.

84. Adams JM, Taylor AE, Schoenfeld DA, Crowley WF Jr., Hall JE. The midcycle gonadotropin surge in normal women occurs in the face of an unchanging gonadotropin-releasing hormone pulse frequency. J Endocrin Metab. 1994; 79:858-864.

85. Leaf A, Jorgensen MB, Jacobs AK, Cote G, Schoenfeld DA, Scheer J, Weiner BH, Slack JD, Kellet MA, Raizner AE, Weber PC, Mahrer PR, Rossouw JE. Do fish oils prevent restenosis post-coronary angioplasty? Circulation. 1994; 90:2248-2257.

86. Hall JE, Taylor AE, Martin KA, Rivier J, Schoenfeld DA, and Crowley WF Jr. Decreased release of gonadotropin-releasing hormone during the preovulatory midcycle luteinizing hormone surge in normal women. Proc Natl Acad Sci. 1994; 91:6894-6898.

87. Hendricks KM, Williams RD, Stoker KW, Schoenfeld DA, Walker WA, Klienman RE. Dietary intake of adolescents with Crohn’s disease. J Amer. Dietetic Assoc. 1994; 94:441-444.

88. Ryan CM, Bailey SH, Carter EA, Schoenfeld DA, Tompkins RG. Additive effects of thermal injury and infection on gut permeability. Arch Surg. 1994; 129:325-328.

89. Klibanski A, Biller BM, Schoenfeld DA, Herzog DB, Saxe VC. The effects of estrogen administration on trabecular bone loss in young women with anorexia nervosa J Clin Endocrinol Metabol. 1995; 80:898-904.

90. Cutrer FM, Schoenfeld D, Limmroth V, Panahian N, Moskowitz MA. Suppression by the sumatriptan analogue, CP-122, 288 of c-fos immunoreactivity in trigeminal nucleus caudalis induced by intracisternal capsaicin. Brit. J Pharmac. 1995; 114:987-992.

91. Ryan CM, Sheridan RL, Schoenfeld DA, Warshaw AL, Tompkins RG. Postburn Pancreatitis. Annals of Surgery. 1995; 222:163-170.

92. Mitlak BH, Burdette-Miller P, Schoenfeld D, Neer RM. Sequential effects of chronic human PTH treatment of estrogen-deficiency osteopenia in the rat. J Bone & Mineral Res. 1996; 11:430-9.

93. Schoenfeld DA. Long-term follow-up in AIDS clinical trials. Stat in Med. 1996; 15: 2359-2366. 94. Pralong FP, Boepple PA, Conn PM, Whitcomb RW, Butler JP, Schoenfeld D, Crowley WF Jr.

Contour of the GnRH pulse independently modulates gonadotropin secretion in the human male. Clinical Neuroendocrinology. 1996; 64; 247-256.

95. Baum HB, Biller BM, Katznelson L, Oppenheim DS, Clemmons DR, Cannistraro KB, Schoenfeld DA, Best SA, Klibanski A. Assessment of growth hormone (GH) secretion in men with Adult-Onset GH deficiency compared with that in normal men--a clinical research center study. J Clin Endocrin & Metab. 1996; 81: 84-92.

96. Lee MM, Donahoe PK, Hasegawa T, Silverman B, Crist GB, Best S, Hasegawa Y, Noto RA, Schoenfeld D, Maclaughlin DT. Mullerian inhibiting substance in humans: normal levels from infancy to adulthood. J Clin Endocrin & Metab. 1996; 81: 571-576.

97. Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Kilbanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrin & Metab. 1996; 81: 4358-4365.

98. Israel EJ, Wilsker DF, Hayes KC, Schoenfeld D, Simister NE. Increased clearance of IgG in mice that lack beta 2-microglobulin: possible protective role of FcRn. Immunology. 1996; 89: 573-578.

99. Baum HBA, Biller BM, Finkelstein JS, Cannistraro KB, Oppenheim DS, Schoenfeld DA, Michel TH, Wittink H, Klibanski A. Effects of Physiologic Growth Hormone Therapy on Bone Density and Body Composition in Patients with Adult-Onset Growth Hormone Deficiency. Ann Intern Med. 1996; 125:883-890.

100. Collier AC, Coombs RW, Schoenfeld DA, Bassett R, Baruch A, Corey L. Combination therapy with zidovudine, didanosine and saquinavir. Antiviral Research. 1996; 2: 91 99-104.

Schoenfeld, David A., Ph.D. (continued)

13

101. Collier AC, Coombs RW, Schoenfeld DA, Bassett RL, Timpone J, Baruch A, Jones M, Facey K, Whitacre C, McAuliffe VJ, Friedman HM, Merigan TC, Reichman RC, Hooper C, Corey L. Treatment of Human Immunodeficiency Virus Infection with Saquinavir, Zidovudine, and Zalcitabine. NEJM. 1996; 334:1011-1017.

102. Finkelstein DM, Schoenfeld DA, Stamenovic E. Analysis of multiple failure time data from an AIDS clinical trial. Stat in Med 1997; 16: 8951-61.

103. Cudkowicz ME, McKenna-Yasek D, Sapp PE, Chin W, Geller B, Hayden DL, Schoenfeld DA, Hosler BA, Horvitz HR, Brown RH. Epidemiology of mutations in superoxide dismutase in amyotrophic lateral sclerosis. Annals of Neurology. 1997; 41: 210-221.

104. Yan G, Shi L, Fu Y, Wang X, Schoenfeld D, Ma L, Penfornis A, Gebel H, Faustman DL. Screening of the TAP1 gene by denaturing gradient gel electrophoresis in insulin-dependent diabetes mellitus: detection and comparison of new polymorphisms between patients and controls. Tissue Antigens 1997; 50:576-585.

105. Ma L, Penfornis A, Wang X, Schoenfeld D, Tuomilehto-Wolf E, Metcalfe K, Hitman G, Faustman D. Evaluation of TAP1 polymorphisms with insulin dependent diabetes mellitus in Finnish diabetic patients. The Childhood Diabetes in Finland (DiMe) Study Group. Human Immunology. 1997; 53: 159-66.

106. Growdon JH, Graefe K, Tennis M, Hayden D, Schoenfeld D, Wray SH. Pupil Dilation to Tropicamide is not Specific for alzheimer disease. Arch Neurol. 1997; 54:841-844.

107. Wee S, Pascul M, Eason JD, Schoenfeld DA, Phelan J, Boskovic S, Blosch C, Mohler K, Cosimi AB. Biological effects and fate of a soluble, dimeric, 80-kDa tumor necrosis factor receptor in renal transplant recipients who receive OKT3 therapy. Transplantation. 1997; 63: 570-577.

108. Grinspoon SK, Askari H, Landt ML, Nathan DM, Schoenfeld DA, Hayden Dl, Laposata M, Hubbard J, Kilbanski A. Effects of fasting and glucose infusion on basal and overnight leptin concentrations in normal-weight women. Am J Clin Nutr. 1997; 66:1352-1356.

109. Taylor AE, McCourt B, Martin KA, Anderson EJ, Adams JM, Schoenfeld D, Hall JE. Determinants of abnormal gonadotropin secretion in clinically defined women with polycystic ovary syndrome. J Clin Endo and Metab. 1997; 82:2248-2256.

110. Welt CK, Martin KA, Taylor AE, Lambert-Messerlian GM, Crowley WF, Jr, Smith JA, Schoenfeld DA, Hall JE. Frequency modulation of follicle-stimulating hormone (FSH) during the luteal-follicular transition: evidence for FSH control of inhibin B in normal women. J Clin Endo & Meta. 1997; 82: 2645-2652.

111. Bakshi SS, Britto P, Capparelli E, Mofenson L, Fowler MG, Rasheed S, Schoenfeld D, Zimmer B, Yitzchak F, Yogev R, Jimenez E, Salgo M, Boone G, Pahwa SG for the ACTG 190 Protocol Team. Evaluation of Pharmacokinetics, Safety, Tolerance and Activity of Combination of Zalcitabine and Zidovudine (ZDV) in Stable, ZDV-Treated, Pediatric Patients with HIV Infection. J Infect Dis. 1997; 175: 1039-1050.

112. Shah A, Laird N, Schoenfeld D. A random-effects model for multiple characteristics with possibly missing data. Journal of the American Statistical Association. 1997; 92(438): 775-779.

113. Collier AC, Schoenfeld D, Hirsch M, van der Horst CM, Ddavis LG, Stanley K, Corey L. Lack of effect on survival of high-dose acyclovir and zidovudine compared with zidovudine alone for immunodeficiency syndrome. Antiviral Therapy. 1998; 8: 25-32.

114. Capano G, Bloch KJ, Carter EA, Dascoli JA, Schoenfeld D, Harmatz PR. Polyamines in Human and Rat Milk Influence Intestinal Cell Growth In Vitro. Journal of Pediatric Gastroenterology and Nutrition. 1998; 27: 281-6.

115. Growdon J, Deng A, Thomsen TM, Mann U, Buhmann J, Sturenburg HJ, Eggers F, Langer U, Velden J, von der Kammer H, Wiegmann H, Hunze S, Naber D, Rebeck B, Schoenfeld D, Hock C, Nitsch R. Cerebrospinal fluid levels of a novel presenilin loop fragment are increased in Alzheimer's disease. Neurology. 1998; 50: S33002-3.

116. Grinspoon S, Corcoran C, Miller K, Wang E, Hubbard J, Schoenfeld D, Anderson E, Basgoz N, Klibanski A. Determinants of increased energy expenditure in HIV-infected women. American Journal of Clinical Nutrition. 1998; 68: 720-5.

Schoenfeld, David A., Ph.D. (continued)

14

117. Katznelson L, Bogan JS, Trob JR, Schoenfeld DA, Hedley-Whyte ET, Hsu DW, Zervas NT, Swearingen B, Sleeper M, Kilbanski A. Biochemical assessment of Cushing’s disease in-patients with corticotroph macroadenomas. J Clin Endocrin & Meta. 1998; 83:1619-1623.

118. Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal Testosterone Administration in Women with Acquired Immunodeficiency Syndrome Wasting: A Pilot Study. J Clin Endo & Meta. 1998; 83: 2717-2725.

119. Baum HB, Katznelson L, Sherman JC, Biller BMK, Hayden DL, Schoenfeld DA, Cannistraro KE, Klibanski A. Effects of Physiological Growth Hormone (GH) Therapy on Cognition and Quality of Life in Patients with Adult-Onset GH Deficiency. J Clin Endo & Meta. 1998; 83: 3184-9.

120. Grinspoon SK, Corcoran C, Askari H, Schoenfeld D, Wolf L, Burrows B, Walsh M, Hayden D, Parlman K, Anderson E, Basgoz N, Kilbanski. Effects of Androgen Administration in Men with the AIDS Wasting Syndrome. Ann Intern Med. 1998; 129:18-26

121. Goggins, William B., Finkelstein, Dianne M., Schoenfeld, David A. and Zaslavsky, Alan M. A Markov chain Monte Carlo EM algorithm for analyzing interval-censored data under the Cox proportional hazards model. Biometrics. 1998; 54, 1498-1507

122. Katznelson L, Rosenthal DI, Rosol MS, Anderson EJ, Hayden DL, Schoenfeld DA, Klibanski A. Using Quantitative CT to Assess Adipose Distribution in Adult Men with Acquired Hypogonadism. Amer J Roentgenology. 1998; 170: 423-7.

123. Ryan CM, Schoenfeld DA, Thorpe WP, Sheridan RL, Cassem EH, Tompkins RG. Objective estimates of the probability of death from burn injuries. NEJM. 1998; 338: 362-366

124. Gilbert JR, Pascual M, Schoenfeld DA, Rubin RH, Delmonico FL, Cosimi AB. Evolving trends in liver transplantation: an outcome and charge analysis. Transplantation. 1999; 67: 246-253.

125. Pascual M, Vallhonrat, H Cosimi A, Tolkoff-Rubin, N Colvin, R Delmonico, F Ko, D Schoenfeld, D Williams W. The Clinical Usefulness of the Renal Allograft Biopsy in the Cyclosporine Era. Transplantation. 1999; 67: 737-41.

126. Worobey J, Schoenfeld D. Eating disordered behavior in dietetics students and students in other majors. Journal of the American Dietetic Association. 1999; 99:1100-2

127. Goff DC. Tsai G. Levitt J. Amico E. Manoach D. Schoenfeld DA. Hayden DL. McCarley R. Coyle JT. A placebo-controlled trial of D-cycloserine added to conventional neuroleptics in patients with schizophrenia. Archives of General Psychiatry. 1999 Jan; 56(1):21-7.

128. Hayes FJ. McNicholl DJ. Schoenfeld D. Marsh EE. Hall JE. Free alpha-subunit is superior to luteinizing hormone as a marker of gonadotropin-releasing hormone despite desensitization at fast pulse frequencies. Journal of Clinical Endocrinology & Metabolism. 84(3):1028-36, 1999 Mar.

129. Finkelstein JS. Schoenfeld DA. Effects of gonadal suppression on the regulation of parathyroid hormone and 1,25-dihydroxyvitamin D secretion in women. Journal of Clinical Endocrinology & Metabolism. 1999 June; 84(6):2151-6.

130. Finkelstein DM. Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Statistics in Medicine. 1999 Jun 15; 18(11):1341-54.

131. Lee MLT, DeGruttola V, Schoenfeld D. A model for markers and latent health status. Journal of the Royal Statistical Society Series B. 2000; 62: 747-52.

132. The ARDS Network. Ketoconazole for early treatment of acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2000; 283: 1995-2002.

133. Leder BZ, Longcope C, Catlin DH, Ahrens B, Schoenfeld DA, Finkelstein JS., Oral androstenedione administration and serum testosterone concentrations in young men. JAMA. 2000; 283: 779-82.

134. The ARDS Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome. NEJM. 2000; 342: 1301-8.

135. Sheridan RL, Hinson MI, Liang MH, Nackel AF, Schoenfeld DA, Ryan CM, Mulligan JL, Tompkins RG. Long-term outcome of children surviving massive burns. JAMA. 2000 Jan 5; 283(1):69-73.

Schoenfeld, David A., Ph.D. (continued)

15

136. Greenberg SM, Tennis MK, Brown LB, Gomez-Isla T, Hayden DL, Schoenfeld DA, Walsh KL, Corwin C, Daffner KR, Friedman P, Meadows ME, Sperling RA, Growdon JH. Donepezil therapy in clinical practice: a randomized crossover study. Archives of Neurology. 2000 Jan; 57(1):94-9.

137. Biller BM, Sesmilo G, Baum HB, Hayden D, Schoenfeld D, Klibanski A. Withdrawal of long-term physiological growth hormone (GH) administration: differential effects on bone density and body composition in men with adult-onset GH deficiency. Journal of Clinical Endocrinology & Metabolism. 2000 Mar; 85(3):970-6.

138. Abrahamian GA, Cosimi AB, Farrell ML, Schoenfeld DA, Chung RT, Pascual M. Prevalence of hepatitis C virus-associated mixed cryoglobulinemia after liver transplantation. Liver Transplantation. 2000 Mar; 6(2):185-90.

139. Yan G, Schoenfeld D, Penney C, Hurxthal K, Taylor AE, Faustman D. Identification of premature ovarian failure patients with underlying autoimmunity. Journal of Womens Health & Gender-Based Medicine. 2000 Apr; 9(3):275-87.

140. Henderson DC, Cagliero E, Gray C, Nasrallah RA, Hayden DL, Schoenfeld DA, Goff DC. Clozapine, diabetes mellitus, weight gain, and lipid abnormalities: A five-year naturalistic study. American Journal of Psychiatry. 2000 Jun; 157(6):975-81.

141. Stafford RS, Farhat JH, Misra B, Schoenfeld DA. National patterns of physician activities related to obesity management. Archives of Family Medicine. 2000 Jul; 9(7):631-8.

142. Grinspoon S, Corcoran C, Parlman K, Costello M, Rosenthal D, Anderson E, Stanley T, Schoenfeld D, Burrows B, Hayden D, Basgoz N, Klibanski A. Effects of testosterone and progressive resistance training in eugonadal men with AIDS wasting. A randomized, controlled trial. Annals of Internal Medicine. 2000 Sep 5; 133(5):348-55.

143. Rubin RH, Kemmerly SA, Conti D, Doran M, Murray BM, Neylan JF, Pappas C, Pitts D, Avery R, Pavlakis M, Del Busto R, DeNofrio D, Blumberg EA, Schoenfeld DA, Donohue T, Fisher SA, Fishman JA. Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis. Transplant Infectious Disease. 2000 Sep; 2(3):112-7.

144. Nitsch RM, Deng M, Tennis M, Schoenfeld D, Growdon JH. The selective muscarinic M1 agonist AF102B decreases levels of total Abeta in cerebrospinal fluid of patients with Alzheimer's disease. Annals of Neurology. 2000 Dec; 48(6):913-8.

145. Lee MLT, Schoenfeld D, Wang X, Faustman D. Bayesian Analysis of Control Polygenic Etiology Studies with Missing Data. Biostatistics. 2001; 2(3): 309-322.

146. Finkelstein DM and Schoenfeld DA. Comparing treatment strategies using a synthesized clinical trial: an analysis of late versus early use of trimethoprim-sulfamethoxazole for AIDS patients. Journal of Statistical Planning and Inference. 2001; 96: 179-189.

147. Miller KK, Sesmilo G, Schiller A, Schoenfeld D, Burton S, Klibanski A. Androgen deficiency in women with hypopituitarism. Journal of Clinical Endocrinology & Metabolism. 2001 Feb; 86(2):561-7.

148. Katznelson L, Kleinberg D, Vance ML, Stravou S, Pulaski KJ, Schoenfeld DA, Hayden DL, Wright ME, Woodburn CJ, Klibanski A. Hypogonadism in patients with acromegaly: data from the multi-centre acromegaly registry pilot study. Clinical Endocrinology. 2001 Feb; 54(2):183-8.

149. Betensky RA and Schoenfeld DA. Nonparametric estimation in a cure model with random cure times. Biometrics. 2001 Mar; 57(1):282-6.

150. Elman I, Krause S, Karlsgodt K, Schoenfeld DA, Gollub RL, Breiter HC, Gastfriend DR. Clinical outcomes following cocaine infusion in nontreatment-seeking individuals with cocaine dependence. Biological Psychiatry. 2001 Mar 15; 49(6):553-5.

151. Spillmann MK, Van der Does AJ, Rankin MA, Vuolo RD, Alpert JE, Nierenberg AA, Rosenbaum JF, Hayden D, Schoenfeld D, Fava M. Tryptophan depletion in SSRI-recovered depressed outpatients. Psychopharmacology. 2001 May; 155(2):123-7.

152. Vallhonrat H, Williams WW, Dec GW, Keck S, Schoenfeld D, Cosimi AB, Pascual M. Complement activation products in plasma after heart transplantation in humans. Transplantation. 2001 May 15; 71(9):1308-11.

Schoenfeld, David A., Ph.D. (continued)

16

153. Fairfield WP, Treat M, Rosenthal DI, Frontera W, Stanley T, Corcoran C, Costello M, Parlman K, Schoenfeld D, Klibanski A, Grinspoon S. Effects of testosterone and exercise on muscle leanness in eugonadal men with AIDS wasting. Journal of Applied Physiology. 2001 Jun; 90(6):2166-71.

154. Smith MR, McGovern FJ, Fallon MA, Schoenfeld D, Kantoff PW, Finkelstein JS. Low bone mineral density in hormone-naive men with prostate carcinoma. Cancer. 2001 Jun 15; 91(12):2238-45.

155. Ryu S, Kodama S, Ryu K, Schoenfeld DA, Faustman DL. Reversal of established autoimmune diabetes by restoration of endogenous beta cell function. Journal of Clinical Investigation. 2001 Jul; 108(1):63-72.

156. Eisner MD, Thompson T, Hudson LD, Luce JM, Hayden D, Schoenfeld D, Matthay MA. Acute Respiratory Distress Syndrome Network. Efficacy of low tidal volume ventilation in patients with different clinical risk factors for acute lung injury and the acute respiratory distress syndrome. American Journal of Respiratory & Critical Care Medicine. 2001 Jul 15; 164(2):231-6.

157. Leder BZ, Catlin DH, Longcope C, Ahrens B, Schoenfeld DA, Finkelstein JS. Metabolism of orally administered androstenedione in young men. Journal of Clinical Endocrinology & Metabolism. 2001 Aug; 86(8):3654-8.

158. Schoenfeld DA. A simple algorithm for designing group sequential clinical trials. Biometrics. 2001 Sep; 57(3):972-4.

159. Smith MR, McGovern FJ, Zietman AL, Fallon MA, Hayden DL, Schoenfeld DA, Kantoff PW, Finkelstein JS. Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer. New England Journal of Medicine. 2001 Sep 27; 345(13):948-55.

160. Baid S, Cosimi AB, Farrell ML, Schoenfeld DA, Feng S, Chung RT, Tolkoff-Rubin N, Pascual M. Posttransplant diabetes mellitus in liver transplant recipients: risk factors, temporal relationship with hepatitis C virus allograft hepatitis, and impact on mortality. Transplantation. 2001 Sep 27; 72(6):1066-72.

161. Shefner JM, Brown RH Jr., Cole D, Chaturvedi P, Schoenfeld D, Pastuszak K, Matthews R, Upton-Rice M, Cudkowicz ME. Effect of neurophilin ligands on motor units in mice with SOD1 ALS mutations. Neurology. 2001 Nov 27; 57(10):1857-61.

162. Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. Journal of Clinical Endocrinology & Metabolism. 2002 Feb; 87(2):599-603.

163. Eisner MD, Thompson BT, Schoenfeld D, Anzueto A, Matthay MA. Acute Respiratory Distress Syndrome Network. Airway pressures and early barotrauma in patients with acute lung injury and acute respiratory distress syndrome. American Journal of Respiratory & Critical Care Medicine. 2002 Apr 1; 165(7):978-82.

164. Finkelstein DM, Goggins WB, Schoenfeld DA. Analysis of failure time data with dependent interval censoring. Biometrics. 2002 Jun; 58(2):298-304.

165. Fidler PE, Mackool BT, Schoenfeld DA, Malloy M, Schulz JT 3rd, Sheridan RL, Ryan CM, Incidence, outcome, and long-term consequences of herpes simplex virus type 1 reactivation presenting as a facial rash in intubated adult burn patients treated with acyclovir. Journal of Trauma-Injury & Critical Care. 2002 Jul; 53(1):86-9.

166. Schoenfeld DA, Bernard GR, ARDS Network. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Critical Care Medicine. 2002 Aug; 30(8):1772-7.

167. Soyka LA, Misra M, Frenchman A, Miller KK, Grinspoon S, Schoenfeld DA, Klibanski A. Abnormal bone mineral accrual in adolescent girls with anorexia nervosa. Journal of Clinical Endocrinology & Metabolism. 2002 Sep; 87(9):4177-85.

168. Ryan CM, Schoenfeld DA, Malloy M, Schulz JT 3rd, Sheridan RL, Tompkins RG. Use of Integra artificial skin is associated with decreased length of stay for severely injured adult burn survivors. Journal of Burn Care & Rehabilitation. 2002 Sep-Oct; 23(5):311-7.

169. Brower RG, Matthay M, Schoenfeld D. Meta-analysis of acute lung injury and acute respiratory distress syndrome trials. Am J Respir Crit Care Med. 2002 Dec 1; 166(11):1515-7.

Schoenfeld, David A., Ph.D. (continued)

17

170. Fava M, Evins AE, Dorer DJ, Schoenfeld DA. The problem of the placebo response in clinical trials of psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom. 2003; 72: 115-127.

171. Leder BZ, LeBlanc KM, Schoenfeld DA, Eastell R, Finkelstein JS. Differential effects of androgens and estrogens on bone turnover in normal men. J Clin Endocrinol Metab. 2003 Jan; 88(1):204-10.

172. Cudkowicz ME, Shefner JM, Schoenfeld DA, et al. A randomized, placebo-controlled trial of topiramate in amyotrophic lateral sclerosis. Neurology. 2003 Aug; 61(2 of 2):456-464.

173. Ancukiewicz M, Finkelstein DM, Schoenfeld DA. Modeling the relationship Between Continuous Covariates and Clinical Events Using Isotonic Regression. Statistics in Medicine. 2003 Oct; 22(20): 3151-3161.

174. Finkelstein DM, Muzikansky A, Schoenfeld DA. Comparing Survival of a Sample to That of a Standard Population. JNCI. 2003 Oct; 95(19): 1434-1439.

175. Brower RG, Morris A, MacIntyre N. Matthay MA, Hayden D, Thompson T, Clemmer T, Lanken PN, Schoenfeld D. ARDS Clinical Trials Network, National Hear, Lung, and Blood Institute, National Institutes of Health. Effects of recruitment maneuvers in patients with acute lung injury and acute respiratory distress syndrome ventilated with high positive end-expiratory pressure. Crit Care Med 2003; 31(11):2592-7.

176. Brower RG, Lanken PN, MacIntyre N. Matthay M, Ancukiewicz M, Schoenfeld D, Thompson BT, National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004; 351:327-326.

177. Sheibani N, Grabowski EF, Schoenfeld DA, Whalen MJ. Effect of granulocyte colony-stimulating factor on functional and histopathologic outcome after traumatic brain injury in mice. Crit Care Med. 2004 Nov; 32(11):2274-8.

178. Traynor BJ, Zhang H, Shefner JM, Schoenfeld DA, Cudkowicz ME, on behalf of the NEALS Consortium. Functional outcome measures as clinical trial endpoints in ALS. Neurology. 2004; 63:1933-1935.

179. Miller KK, Rosner W, Lee H, Hier J, Sesmilo G, Schoenfeld D, Neubauer G, Klibanski A. Measurement of free testosterone in normal women and women with androgen deficiency: comparison of methods. Journal of Clinical Endocrinology & Metabolism. 2004 Feb; 89(2):525-33.

180. Shefner JM, Cudkowicz ME, Schoenfeld D, Conrad T, Taft J, Chilton M, Urbinelli L, Qureshi M, Zhang H, Pestronk A, Caress J, Donofrio P, Sorenson E, Bradley W, Lomen-Hoerth C, Pioro E, Rezania K, Ross M, Pascuzzi R, Heiman-Patterson T, Tandan R, Mitsumoto H, Rothstein J, Smith-Palmer T, MacDonald D, Burke D, NEALS Consortium. A clinical trial of creatine in ALS. Neurology. 2004 Nov 9; 63(9):1656-61.

181. Feezor RJ, Baker HV, Mindrinos M, Hayden D, Tannahill CL, Brownstein BH, Fay A, MacMillan S, Laramie J, Xiao W, Moldawer LL, Cobb JP, Laudanski K, Miller-Graziano CL, Maier RV, Schoenfeld D, Davis RW, Tompkins RG. Inflammation and Host Response to Injury, Large-Scale Collaborative Research Program. Whole blood and leukocyte RNA isolation for gene expression analyses. Physiological Genomics. 2004 Nov 17; 19(3):247-54.

182. Cudkowicz M, Zhang H, Qureshi M, Schoenfeld D. Maximum voluntary isometric contraction (MVIC). Amyotrophic Lateral Sclerosis & Other Motor Neuron Disorders. 2004 Sep; 5 Suppl 1:84-5.

183. Shefner JM, Cudkowicz ME, Zhang H, Schoenfeld D, Jillapalli D, Northeast ALS Consortium. The use of statistical MUNE in a multicenter clinical trial. Muscle & Nerve. 2004 Oct; 30(4):463-9.

184. Delgado-Borrego A, Casson D, Schoenfeld D, Somsouk M, Terella A, Jordan SH, Bhan A, Baid S, Cosimi AB, Pascual M, Chung RT. Hepatitis C virus is independently associated with increased insulin resistance after liver transplantation. Transplantation. 2004 Mar 15; 77(5):703-10.

185. Copeland S, Warren HS, Lowry SF, Calvano SE, Remick D; Inflammation and the Host Response to Injury Investigators. Acute inflammatory response to endotoxin in mice and humans. Clin Diagn Lab Immunol. 2005 Jan; 12(1):60-7.

Schoenfeld, David A., Ph.D. (continued)

18

186. Cobb JP, Mindrinos MN, Miller-Graziano C, Calvano SE, Baker HV, Xiao W, Laudanski K, Brownstein BH, Elson CM, Hayden DL, Herndon DN, Lowry SF, Maier RV, Schoenfeld DA, Moldawer LL, Davis RW, Tompkins RG, Baker HV, Bankey P, Billiar T, Brownstein BH, Calvano SE, Camp D, Chaudry I, Cobb JP, Davis RW, Elson CM, Freeman B, Gamelli R, Gibran N, Harbrecht B, Hayden DL, Heagy W, Heimbach D, Herndon DN, Horton J, Hunt J, Laudanski K, Lederer J, Lowry SF, Maier RV, Mannick J, McKinley B, Miller-Graziano C, Mindrinos MN, Minei J, Moldawer LL, Moore E, Moore F, Munford R, Nathens A, O'Keefe G, Purdue G, Rahme L, Remick D, Sailors M, Schoenfeld DA, Shapiro M, Silver G, Smith R, Stephanopoulos G, Stormo G, Tompkins RG, Toner M, Warren S, West M, Wolfe S, Xiao W, Young V. Inflammation and Host Response to Injury Large-Scale Collaborative Research Program. Application of genome-wide expression analysis to human health and disease. Proceedings of the National Academy of Sciences of the United States of America. 2005 Mar 29; 102(13):4801-6.

187. Evins AE, Cather C, Deckersbach T, Freudenreich O, Culhane M, Olm-Shipman 1CM, Henderson DC, Schoenfeld DA, Goff DC, Rigotti NA. A double-blind placebo-controlled trial of bupropion sustained-release for smoking cessation in schizophrenia. J Clin Psychopharmacol. 2005 Jun; 25(3):218-25.

188. De AK, Miller-Graziano CL, Calvano SE, Laudanski K, Lowry SF, Moldawer LL, Remick DG Jr., Rajicic N, Schoenfeld D, Tompkins RG. Selective activation of peripheral blood T cell subsets by endotoxin infusion in healthy human subjects corresponds to differential chemokine activation. Journal of Immunology. 2005 Nov 1; 175(9):6155-62.

189. Evins AE, Deckersbach T, Cather C, Freudenreich O, Culhane MA, Henderson DC, Green MF, Schoenfeld DA, Rigotti NA, Goff DC. Independent effects of tobacco abstinence and bupropion on cognitive function in schizophrenia. Journal of Clinical Psychiatry. 2005 Sep; 66(9):1184-90.

190. Goff DC, Herz L, Posever T, Shih V, Tsai G, Henderson DC, Freudenreich O, Evins AE, Yovel I, Zhang H, Schoenfeld D. A six-month, placebo-controlled trial of D-cycloserine co-administered with conventional antipsychotics in schizophrenia patients. Psychopharmacology. 2005 Apr; 179(1):144-50.

191. Cardarelli F, Pascual M, Tolkoff-Rubin N, Delmonico FL, Wong W, Schoenfeld DA, Zhang H, Cosimi AB, Saidman SL. Prevalence and significance of anti-HLA and donor-specific antibodies long-term after renal transplantation. Transplant International. 2005 May; 18(5):532-40.

192. Dolan SE, Hadigan C, Killilea KM, Sullivan MP, Hemphill L, Lees RS, Schoenfeld D, Grinspoon S. Increased cardiovascular disease risk indices in HIV-infected women. J Acquir Immune Defic Syndr. 2005 May 1; 39(1):44-54.

193. Henderson DC, Cagliero E, Copeland PM, Borba CP, Evins E, Hayden D, Weber, MT, Anderson EJ, Allison DB, Daley TB, Schoenfeld DA, Goff DC. Glucose Metabolism in Patients With Schizophrenia Treated With Atypical Antipsychotic Agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry. 2005; 62:19-28.

194. Schoenfeld DA and Borenstein M. Calculating the power or sample size for the logistic and proportional hazards models. J Stat Computation and Simulation. 2005; 75(10): 771-85.

195. Hayden D, Pauler DK, Schoenfeld D. An Estimator for Treatment Comparisons among Survivors in Randomized Trials. Biometrics. 2005 March; 61(1):305-10.

196. Maier RV, Bankey P, Freeman B, Harbrecht BG, Johnson JL, McKinley B, Minei JP, Moore EE, Moore F, Nathens AB, Shapiro M, West M, Tompkins RB. The Inflammation and the Host Response to Injury Large-Scale Collaborative Research Program. SOPs for the Severely Injured Patient. Journal of Trauma Injury, Infection and Critical Care. 2005 Sep; 59(3):764-769.

197. Nathens AB, Johnson JL, Minei JP, Moore EE, Shapiro M, Bankey P, Freeman B, Harbrecht BG, Lowry SF, McKinley B, Moore F, West M, Maier RV; Inflammation and the Host Response to Injury Investigators. Inflammation and the Host Response to Injury, a large-scale collaborative project: Patient-Oriented Research Core--standard operating procedures for clinical care. I. Guidelines for mechanical ventilation of the trauma patient. J Trauma. 2005 Sep; 59(3):764-9.

198. Calvano SE, Xiao W, Richards DR, Felciano RM, Baker HV, Cho RJ, Chen RO, Brownstein BH, Cobb JP, Tschoeke SK, Miller-Graziano C, Moldawer LL, Mindrinos MN, Davis RW, Tompkins

Schoenfeld, David A., Ph.D. (continued)

19

RG, Lowry SF; Inflamm and Host Response to Injury Large Scale Collab. Res. Program. A network-based analysis of systemic inflammation in humans. Nature. 2005 Dec 1;438(7068):696.

199. Leaf A, Albert CM, Josephson M, Steinhaus D, Kluger J, Kang JX, Cox B, Zhang H, Schoenfeld D. Fatty Acid Antiarrhythmia Trial Investigators. Prevention of fatal arrhythmias in high-risk subjects by fish oil n-3 fatty acid intake. Circulation. 2005 Nov 1; 112(18):2762-8.

200. Bernard H Brownstein, Tanya Logvinenko, James A Lederer, J. Perren Cobb1, William J Hubbard, Irshad H Chaudry, Daniel G Remick, Henry V Baker, Wenzhong Xiao, John A Mannick, and The Inflammation and the Host Response to Injury investigators. Commonality and differences in leukocyte gene expression patterns among three models of inflammation and injury. Physiol Genomics. 2006 Feb 14; 24(3):298-309.

201. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wheeler AP, Bernard GR, Thompson BT, Schoenfeld D, Wiedemann HP, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Pulmonary-Artery versus Central Venous Catheter to Guide Treatment of Acute Lung Injury. N Engl J Med. 2006 May 25; 354(21):2213-24.

202. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of Two Fluid-Management Strategies in Acute Lung Injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. Epub 2006 May 21.

203. Hersch SM, Gevorkian S, Marder K, Moskowitz C, Feigin A, Cox M, Como P, Zimmerman C, Lin M, Zhang L, Ulug AM, Beal MF, Matson W, Bogdanov M, Ebbel E, Zaleta A, Kaneko Y, Jenkins B, Hevelone N, Zhang H, Yu H, Schoenfeld D, Ferrante R, Rosas HD. Creatine in Huntington disease is safe, tolerable, bioavailable in brain and reduces serum 8OH2'dG. Neurology. 2006 Jan 24; 66(2):250-2.

204. The National Heart, Lung and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med. 2006 April; 354:1671-84.

205. Henderson DC, Copeland PM, Borba CP, Daley TB, Nguyen DD, Cagliero E, Evins AE, Zhang H, Hayden DL, Freudenreich O, Cather C, Schoenfeld DA, Goff DC. Glucose metabolism in patients with schizophrenia treated with olanzapine or quetiapine: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Journal of Clinical Psychiatry. 2006 May; 67(5):789-97.

206. Miller KK, Biller BM, Beauregard C, Lipman JG, Jones J, Schoenfeld D, Sherman JC, Swearingen B, Loeffler J, Klibanski A. Effects of testosterone replacement in androgen-deficient women with hypopituitarism: a randomized, double-blind, placebo-controlled study. Journal of Clinical Endocrinology & Metabolism. 2006 May; 91(5):1683-90.

207. Cudkowicz ME, Shefner JM, Schoenfeld DA, Zhang H, Andreasson KI, Rothstein JD, Drachman DB, Northeast ALS Consortium. Trial of celecoxib in amyotrophic lateral sclerosis. Annals of Neurology. 2006 Jul; 60(1):22-31.

208. Wheeler AP, Wiedemann HP, Schoenfeld DA, Catheters and the treatment of acute lung injury-Reply. New England Journal of Medicine. 2006 Aug; 355(9):958.

209. Rajicic N, Finkelstein DM, Schoenfeld DA. The Inflammation and Host Response to Injury Research Program Investigators. Survival analysis of longitudinal microarrays. Bioinformatics. 2006 Nov; 22:2643-2649.

210. Cudkowicz ME, Andres PL, Schoenfeld DA. Safety and dose escalating study of oral sodium phenylbutyrate in subjects with ALS. Neurology, 2007.

211. Rao RS, Schoenfeld DA. Survival methods in cardiovascular research. Circulation. 2007 Jan 2; 115:109-113.

212. Shefner JM, Cudkowicz ME, Zhang H, Schoenfeld DA, Jillapalli D. Revised statistical motor unit number estimation in the Celecoxib/ALS. Muscle Nerve. 2007 Feb; 35(2): 228-234.

213. Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn injury: a multicenter study. Ann Surg. 2007 April; 245(4):622-8.

Schoenfeld, David A., Ph.D. (continued)

20

214. Evins AE, Cather C, Deckersbauch T, Freudenreich O, Henderson DC, Schoenfeld DA, Goff DC, Rigotti NA. Smoking cessation in schizophrenia- Reply to comments by Dr. Babbar. Journal of Clinical Psychopharmacology.2007 April; 27 (2):240.

215. Rice TW, Wheeler AP, Schoenfeld DA, et al. Comparison of the Sp02/FI02 ratio in patients with acute lung injury or ARDS. Chest. 2007 Aug; 132(2): 410-7.

216. Evins AE, Cather C, Culhand MA, Birnbaum A, Horowitz J, Hseish E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12 week double blind, placebo controlled study of bupropion sr added to high dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J of Clin Psychopharmacol. 2007 Aug; 27(4):380-6.

217. Thompson BT, Schoenfeld DA. Usual care as the control group in clinical trials of nonpharmacologic interventions. Proc Am Thoracic Soc. 2007 Oct; 4 (7): 577-82.

218. Rutkovs SB, Zhang H, Schoenfeld DA, Ratnor EM, Shefner JM, Cudkowicz ME, Chin AB, Aaron R, Shiffman CA. Electrical impedance myography to assess lateral sclerosis clinical trials. Clin Neurophysiol. 2007 Nov; 118(11):2413-8.

219. Conrad C, Zhu J, Conrad C, Schoenfeld DA, Fang Z, Ingelss M, Stamm S, Church G, Hyman B. Single molecule profiling of tau gene expression in Alzheimer’s disease. J Neurochem. 2007 Nov; 103(3):1228-36.

220. Morris AH, Orme J Jr, Truwit JD, Steingrub J, Grissom C, Lee KH, Li GL, Thompson BT, Brower R, Tidswell M, Bernard GR, Sorenson D, Sward K, Zheng H, Schoenfeld D, Warner H. A replicable method for blood glucose control in critically ill patients. Crit Care Med. 2008 Jun; 36(6):1787-95.

221. Cudkowicz ME, Shefner JM, Simpson E, Grasso D, Yu H, Zhang H, Shui A, Schoenfeld D, Brown RH, Wieland S, Barber JR, Northeast ALS Consortium. Arimoclomol at dosages up to 300 mg/day is well tolerated and safe in amyotrophic lateral sclerosis. Muscle Nerve. 2008 Jul; 38(1):837-44.

222. Tsoulfas G, Hertl M, Ko DSC, Elias N, Delmonico FL, Romano L, Fernandes I, Schoenfeld D, Kawai T. Long-term outcome of a cuffed expanded PTFE graft for hemodialysis vascular access. World Journal of Surgery. 2008 Aug; 32 (8):1827-31.

223. Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ, For the A1c-Derived Average Glucose (ADAG) Study Group. Translating the A1C assay into estimated average glucose values. Diabetes Care. 2008 Aug; 31(8):1-6.

224. Culhane MA, Schoenfeld DA, Barr RS, Cather C, Deckersbach T, Freudenreich O, Goff DC, Rigotti NA, Evins AE. Predicators of early abstinence in smokers with schizophrenia. Journal of Clinical Psychiatry. 2008 Nov; 69(11):1743-50.

225. Goff DC, Cather C, Gottlieb JD, Evins AE, Walsh J, Raeke L, Otto MW, Schoenfeld D, Green MF. Once weekly D-cycloserine effects on negative symptoms and cognition in schizophrenia: an exploratory study. Schizophrenia Research. 2008 Dec; 106(2-3):320-7.

226. Qureshi M, Shui A, Dibernardo AB, Brown RH Jr, Schoenfeld DA, Cudkowicz ME. Medications and laboratory parameters as prognostic factors in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2008 Dec; 9(6):369-74.

227. Schoenfeld DA, Cudkowicz M. Design of phase II ALS clinical trials. Amyotrophic Lateral Sclerosis. 2008; 9(1):16-23.

228. Bredella MA, Utz AL, Torriani M, Thomas B, Schoenfeld DA, Miller KK. Anthropometry, CT and DXA as predicators of GH deficiency in premenopausal women: ROC curve analysis. J Appl Physiol. 2009 Feb; 106: 418-422.

229. Cudkowicz ME, Andres PL, Macdonald SA, Bedlack RS, Choudry R, Brown RH Jr, Zhang H, Schoenfeld DA, Shefner J, Matson S, Matson WR, Ferrante RJ; Northeast ALS and National VA ALS Research Consortiums. Phase 2 study of sodium phenylbutyrate in ALS. Amyotrophic Lateral Sclerosis. 2009 Apr; 10(2):99-106.

230. Hayden D, Lazar P, Schoenfeld DA, The Inflammation and the Host Response to Injury Investigators. Assessing statistical significance in microarray experiments using the distance between microarrays. PLoS ONE. 2009 Jun 16; 4(6).

231. Qureshi M, Schoenfeld DA, Paliwal Y, Shui A, Cudkowicz ME. The natural history of ALS is changing: Improved survival. Amyotroph Lateral Scler. 2009 Jun; 1:1-18.

Schoenfeld, David A., Ph.D. (continued)

21

232. Warren HS, Elson CM, Hayden DL, Schoenfeld DA, Cobb JP, Maier RV, Moldawer LL, Moore EE, Harbrecht BG, Pelak K, Cuschieri J, Herndon DN, Jeschke MG, Finnerty CC, Brownstein BH, Hennessy L, Mason PH, Tompkins RG, Inflammation and Host Response to Injury Large Scale Collaborative Research Program. A Genomic Score Prognostic of Outcome in Trauma Patients. Mol MED. 2009 Jul-Aug; 15(7-8):220-227.

233. Rajicic N, Finkelstein DM, Schoenfeld DA, and the Inflammation and the Host Response to Injury Research Program Investigators. Analysis of the relationship between longitudinal gene expressions and ordered categorical event data. Statistics in Medicine. 2009 Jul; 28(22):2817-2832.

234. Schoenfeld DA, Zheng H, Finkelstein D. Bayesian design using adult data to augment pediatric trials. Clinical Trials. 2009 Aug; 6(4): 297-304.

235. Grissom CK, Morris AH, Lanken PN, Ancukiewicz M, Orme JF Jr, Schoenfeld DA, Thompson BT; National Institutes of Health/National Heart, Lung and Blood Institute Acute Respiratory Distress. Association of physical examination with pulmonary artery catheter parameters in acute lung injury. Critical Care Med. 2009 Oct; 37(10): 2720-2726.

236. Cobb JP, Moore EE, Hayden DL, Minei JP, Cuschieri J, Yang J, Li Q, Lin N, Brownstein BH, Hennessy L, Mason PH, Schierding WS, Dixon DJ, Tompkins RG, Warren HS, Schoenfeld DA, Maier RV. Validation of the Riboleukogram to Detect Ventilator-Associated Pneumonia after Severe Injury. Annals of Surgery. 2009 Oct; 250(4):531-539.

237. Borg R, Nerup J, Nathan DM, Kuenen J, Zheng H, Schoenfeld D, Heine RJ, ADAG-studiegruppen. Glycated haemoglobin may in future be reported as estimated mean blood glucose concentration--secondary publication. Ugeskr Laeger. 2009 Nov. 2; 171(45):3262-5.

238. Lesser EA, Gozani SN, Kong X, Schoenfeld DA. Implementation and Evaluation of Statistical Framework for Nerve Connection Study Reference Range Calculation. Comput Methods Programs Biomed. 2010 Jan; 97(1):1-10.

239. Aggarwal SP, Zinman L, Simpson E, McKinley J, Jackson KE, Pinto H, Kaufman P, Conwit RA, Schoenfeld D, Shefner J, Cudkowicz M, Northeast and Canadian Amyotrophic Lateral Sclerosis consortia. Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet neurol. 2010 May; 9(5):481-8.

240. Cudkowicz ME, Katz J, Moore DH, O'Neill G, Glass JD, Mitsumoto H, Appel S, Ravina B, Kieburtz K, Shoulson I, Kaufmann P, Khan J, Simpson E, Shefner J, Levin B, Cwik V, Schoenfeld D, Aggarwal S, McDermott MP, Miller RG. Toward more efficient clinical trials for amyotrophic lateral sclerosis. Amyotroph lateral scler. 2010 May 3; 11(3):259-65

241. Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond Mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15; 181(10):1121-7.

242. Zhou B, Xu W, Herndon D, Tompkins R, Davis R, Xiao W, Wong WH, Inflammation and Host Response to Injury Program, Toner M, Warren HS, Schoenfeld DA, Rahme L, McDonald-Smith GP, Hayden D, Mason P, Fagan S, Yu YM, Cobb JP, Remick DG, Mannick JA, Lederer JA, Gamelli RL, Silver GM, West MA, Shapiro MB, Smith R, Camp DG 2nd, Qian W, Storey J, Mindrinos M, Tibshirani R, Lowry S, Calvano S, Chaudry I, West MA, Cohen M, Moore EE, Johnson J, Moldawer LL, Baker HV, Efron PA, Balis UG, Billiar TR, Ochoa JB, Sperry JL, Miller-Graziano CL, De AK, Bankey PE, Finnerty CC, Jeschke MG, Minei JP, Arnoldo BD, Hunt JL, Horton J, Cobb JP, Brownstein B, Freeman B, Maier RV, Nathens AB, Cuschieri J, Gibran N, Klein M, O'Keefe G. Analysis of factorial time-course microarrays with application to a clinical study of burn injury. Proc Natl Acad Sci U S A. 2010 Jun 1; 107(22):9923-8.

243. Finkelstein D, Wang R, Ficociello, Schoenfeld DA. A score test for association of a longitudinal marker and an event with missing data. Biometrics. 2010 Sep; 66(3):726-32.

244. Royce-Nagel G, Cudkowicz M, Myers D, Nicholson K, Shui A, Schoenfeld D, Huang X, Brown RH. Vanadium, aluminum, magnesium and manganese are not elevated in hair samples in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis. 2010 Oct; 11: 492-493.

Schoenfeld, David A., Ph.D. (continued)

22

245. Rajicic N, Cuschieri J, Finkelstein DM, Miller-Grazian CL, Hayden D, Moldawer LL, Moore E, O’Keefe G, Pelik K, Warren HS, Schoenfeld DA, and the Inflammation and the Host Response to Injury Large Scale Collaborative Research Program. Identification and Interpretation of Longitudinal Gene Expression Changes in Trauma. PLoS One. 2010 Dec 20; 5(12):e14380.

246. Yeh H, Smoot, E, Schoenfeld DA, Markmann JF. Geographic inequity in access to livers for transplantation. Transplantation. 2011Feb 27; 91(4): 479-86.

247. Finkelstein DM, Schoenfeld DA. Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 trial by using the inverse probability of censoring weighted method. J Clin Oncol. 2011 Mar 20; 29(9):1117-24.

248. Schoenfeld DA, Rajicic N, Ficociello LH, Finkelstein DM. A test for the relationship between a time-varying marker and both recovery and progression with missing data. Stat Med. 2011Mar 30; 30(7):718-24.

249. Li A, Zhou C, Moore J, Zhang P, Tsai TH, Lee HC, Romano DM, McKee ML, Schoenfeld DA, Serra MJ, Raygor K, Cantiello HF, Fujimoto JG, Tanzi RE.. Changes in the expression of the Alzheimer’s Disease- Associated Presenilin gene in drosophila heart leads to cardiac dysfunction. Curr Alzheimer Res. 2011May 1; 8(3):313-322.

250. Zheng H, Nathan DM, Schoenfeld DA. Using A Multi-Level B-Spline Model to Analyze and Compare Patient Glucose Profiles Based on Continuous Monitoring Data. Diabetes Technology and Therapeutics. 2011 Jun; 13(6):675-682.

251. Kennealey PT, Elias N, Hertl M, Ko DS, Saidi RF, Markmann JF, Smoot EE, Schoenfeld DA, Kawai T. A prospective, randomized comparison of bovine carotid artery and expanded polytetrafluoroethylene for permanent hemodialysis vascular access. J Vasc Surg. 2011 Jun; 53(6):1640-8.

252. Nadazdin O, Abrahamian G, Boskovic S, Smith RN, Schoenfeld DA, Madsen JC, Colvin RB, Sachs DH, Cosimi AN, Kawai T. Stem cell mobilization and collection for induction of mixed chimerism and renal allograft tolerance in cynomolgus monkeys. J Surg Res. 2011 Jun 15; 168(2):294-300.

253. Miller KK, Meenaghan E, Lawson EA, Misra M, Gleysteen S, Schoenfeld D, Herzog D, Klibanski A. Effects of risedronate and low-dose transdermal testosterone on bone density in women with anorexia nervosa: a randomized, placebo-controlled study. J Clin Endocrinol Metab. 2011 Jul;96(7):2081-8.

254. Atassi N, Cudkowicz ME, Schoenfeld DA. Advanced Statistical Methods to Study of the Effects of Gastric Tube and Non-Invasive Ventilation on Functional Decline and Survival in Amyotrophic Lateral Sclerosis. Amyotroph Lateral Scler. 2011 Jul; 12(4):272-7.

255. Ivanova A, Qaqish B, Schoenfeld, DA. Optimality, sample size, and power calculations for the sequential parallel comparison design. Statistics in Medicine. 2011 Jul; 30: 2793-2803.

256. Misra M, Katzman D, Miller KK, Mendes N, Snelgrove D, Russell M, Goldstein MA, Ebrahimi S, Clauss L, Weigel T, Mickley D, Schoenfeld DA, Herzog DB, Klibanski A. Physiologic estrogen replacement increases bone density in adolescent girls with anorexia nervosa. J Bone Miner Res. 2011 Oct; 26(10):2430-8. doi: 10.1002/jbmr.447.

257. Morse RE, Nadkarni P, Schoenfeld DA, Finkelstein DM. Web-browser encryption of personal health information. BMC Med Inform Decis Mak. 2011 Nov 10; 11(1): 70.

258. van Blitterswijk M, Gulati S, Smoot E, Jaffa M, Maher N, Hyman BT, Ivinson AJ, Scherzer CR, Schoenfeld DA, Cudkowicz ME, Brown RH, Bosco DA. Anti-superoxide dismutase antibodies are associated with survival in patients with sporadic amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2011 Nov;12(6):430-8.

259. Cobb JP, Hayden DL, Schoenfeld DA. Novel diagnostics for sepsis: A decade of promise for gene expression profiling. Crit Care Med. 2011 Nov;39(11):2579-81.

260. Randolph AG, Vaughn F, Sullivan R, Rubinson L, Thompson BT, Yoon G, Smoot E, Rice TW, Loftis LL, Helfaer M, Doctor A, Paden M, Flori H, Babbitt C, Graciano AL, Gedeit R, Sanders RC, Giuliano JS, Zimmerman J, Uyeki TM; the Pediatric Acute Lung Injury and Sepsis Investigator's Network and the National Heart, Lung, and Blood Institute ARDS Clinical Trials

Schoenfeld, David A., Ph.D. (continued)

23

Network. Critically Ill Children During the 2009-2010 Influenza Pandemic in the United States. Pediatrics. 2011 Dec; 128(6):e1450-8.

261. Andres PL, Skerry LM, Munsat TL, Thornell BJ, Symonifka J, Schoenfeld DA, Cudkowicz ME. Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials. Muscle Nerve. 2012 Jan; 45(1):81-5.

262. Perlstein TS, Goldhaber SZ, Nelson K, Joshi V, Morgan TV, Lesko LJ, Lee JY, Gobburu J, Schoenfeld D, Kucherlapati R, Freeman MW, Creager MA. The Creating an Optimal Warfarin Nomogram (CROWN) Study. Thromb Haemost. 2012 Jan; 107(1):59-68.

263. Larocque RC, Rao SR, Lee J, Ansdell V, Yates JA, Schwartz BS, Knouse M, Cahill J, Hagmann S, Vinetz J, Connor BA, Goad JA, Oladele A, Alvarez S, Stauffer W, Walker P, Kozarsky P, Franco-Paredes C, Dismukes R, Rosen J, Hynes NA, Jacquerioz F, McLellan S, Hale D, Sofarelli T, Schoenfeld D, Marano N, Brunette G, Jentes ES, Yanni E, Sotir MJ, Ryan ET; the Global TravEpiNet Consortium. Global TravEpiNet: A National Consortium of Clinics Providing Care to International Travelers--Analysis of Demographic Characteristics, Travel Destinations, and Pretravel Healthcare of High-Risk US International Travelers, 2009-2011. Clin Infect Dis. 2012 Feb 15; 54(4):455-62.

264. Schoenfeld DA, Hayden D, Oldmixon C, Ringwood N, Thompson BT. Statistical design and analysis issues for the ARDS Clinical Trials Network: the Coordinating Center perspective. Clin Invest. 2012 Mar; 2(3): 275-289.

265. Hoffmann, U ; Truong, QA ; Fleg, JL ; Goehler, A ; Gazelle, S ; Wiviott, S ; Lee, H ; Udelson, JE ; Schoenfeld, D. Design of the Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography: A multicenter randomized comparative effectiveness trial of cardiac computed tomography versus alternative triage strategies in patients with acute chest pain in the emergency department. American Heart Journal, 2012, Vol.163(3), pp.330-U269

266. Bredella MA, Lin E, Brick DJ, Gerweck AV, Harrington LM, Torriani T, Thomas BJ, Schoenfeld DA, Breggia A, Rosen CJ, Hemphill LC, Wu Z, Rifai N, Utz AL, Miller KK. Effects of growth hormone in women with abdominal adiposity: a 6-month randomized, double-blind, placebo-controlled trial. Eur J Endocrinol. 2012 Apr; 166(4):601-611.

267. Greer DM, Yang J, Scripko PD, Sims JR 3rd, Cash S, Kilbride R, Wu O, Hafler JP, Schoenfeld DA, Furie KL. Clinical examination for outcome prediction in nontraumatic coma. Crit Care Med. 2012 Apr; 40(4):1150-1156.

268. Cuschieri J, Johnson JL, Sperry J, West MA, Moore EE, Minei JP, Bankey PE, Nathens AB, Cuenca AG, Efron PA, Hennessy L, Xiao W, Mindrinos MN, McDonald-Smith GP, Mason PH, Billiar TR, Schoenfeld DA, Warren HS, Cobb JP, Moldawer LL, Davis RW, Maier RV, Tompkins RG; Inflammation and Host Response to Injury, Large Scale Collaborative Research Program. Benchmarking outcomes in the critically injured trauma patient and the effect of implementing standard operating procedures. Ann Surg. 2012 May;255(5):993-9.

269. Brown-Endres, L ; Schoenfeld DA; Tian, F ; Kim, HG ; Namba, T ; Munoz-Fontela, C ; Mandinova, A ; Aaronson, SA ; Lee, SW Expression of the p53 Target CDIP Correlates with Sensitivity to TNF alpha-Induced Apoptosis in Cancer Cells Cancer Research, 2012, Vol.72(9), pp.2373-2382

270. Hoffmann U, Truong QA, Schoenfeld DA, Chou ET, Woodard PK, Nagurney JT, Pope JH, Hauser TH, White CS, Weiner SG, Kalanjian S, Mullins ME, Mikati I, Peacock WF, Zakroysky P, Hayden D, Goehler A, Lee H, Gazelle GS, Wiviott SD, Fleg JL, Udelson JE; ROMICAT-II Investigators. Coronary CT angiography versus standard evaluation in acute chest pain. N Engl J Med. 2012 Jul 26;367(4):299-308.

271. Faustman DL, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM. Proof of concept, randomized, controlled clinical trial of bacillus calmette guerin for treatment of long term Type 1 diabetes. PLoS One. 2012 Aug; 7(8): e41756.

272. Aoyama A, Klarin D, Yamada Y, Boskovic S, Nadazdin O, Kawai K, Schoenfeld D, Madsen JC, Cosimi AB, Benichou G, Kawai T. Low-dose IL-2 for In vivo expansion of CD4+ and CD8+ regulatory T cells in nonhuman primates. Am J Transplant. 2012 Sep;12(9):2532-7.

Schoenfeld, David A., Ph.D. (continued)

24

273. Healy, B. C. and Schoenfeld, D. (2012), Comparison of analysis approaches for phase III clinical trials in amyotrophic lateral sclerosis. Muscle Nerve, 46: 506–511.

274. Lin E, Bredella M, Gerweck A, Landa M, Schoenfeld D, Utz A, Miller K. Effects of Growth Hormone Withdrawal in Obese Premenopausal Women. Clin Endocrinol (Oxf). 2012 Nov 12.

275. Papakostas GI, Shelton RC, Zajecka JM, Etemad B, Rickels K, Clain A, Baer L, Dalton ED, Sacco GR, Schoenfeld D, Pencina M, Meisner A, Bottiglieri T, Nelson E, Mischoulon D, Alpert JE, Barbee JG, Zisook S, Fava M. L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials. Am J Psychiatry. 2012 Dec 1;169(12):1267-74.

276. Melanie Leitner, Alexander Sherman, Nazem Atassi, James Berry, Amy Shui, Neta Zach, Jason Walker, Ervin Sinani, Igor Katsovskiy, David Schoenfeld and Merit Cudkowicz ALS Enters the World of Big Data: Initial Description of and Results from the PRO-ACT Platform Neurology February 12, 2013; 80(Meeting Abstracts 1): P07.064

277. Andres PL, English R, Mendoza M, Florence J, Malkus E, Schierbecker J, Siener C, Malspeis S, Schoenfeld DA, Munsat TL, Cudkowicz ME. Developing normalized strength scores for neuromuscular research. Muscle Nerve. 2013 Feb;47(2):177-82.

278. Seok J, Warren HS, Cuenca AG, Mindrinos MN, Baker HV, Xu W, Richards DR, McDonald-Smith GP, Gao H, Hennessy L, Finnerty CC, López CM, Honari S, Moore EE, Minei JP, Cuschieri J, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Jeschke MG, Klein MB, Gamelli RL, Gibran NS, Brownstein BH, Miller-Graziano C, Calvano SE, Mason PH, Cobb JP, Rahme LG, Lowry SF, Maier RV, Moldawer LL, Herndon DN, Davis RW, Xiao W, Tompkins RG; Inflammation and Host Response to Injury, Large Scale Collaborative Research Program. Genomic responses in mouse models poorly mimic human inflammatory diseases. Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3507-12.

279. Eric T. Chou; Pearl Zakroysky; Doug Hayden; Pamela Woodard; Stephen Wiviott; John Nagurney; Jerome Fleg; Hang Lee; David Schoenfeld; Udo Hoffmann; Quynh Truong Utility of coronary artery calcium scanning in emergency department evaluation for acute chest pain: the ROMICAT II trial. J Am Coll Cardiol. 2013;61(10_S):

280. James L. Januzzi; Pearl Zakroysky; Quynh Truong; Pamela Woodard; James Hector Pope; Thomas Hauser; John Nagurney; David Schoenfeld; W. Frank Peacock; Stephen Wiviott; Peter Pang; James Udelson; Udo Hoffmann Performance of two sensitive Troponin I assays for the evaluation of suspected ACS: Results from the multicenter rule out myocardial infarction using computer assisted tomography (ROMICAT) II biomarker sub-study. J Am Coll Cardiol. March 2013;61(10_S)

281. Finnerty CC, Jeschke MG, Qian WJ, Kaushal A, Xiao W, Liu T, Gritsenko MA, Moore RJ, Camp DG 2nd, Moldawer LL, Elson C, Schoenfeld D, Gamelli R, Gibran N, Klein M, Arnoldo B, Remick D, Smith RD, Davis R, Tompkins RG, Herndon DN; Investigators of the Inflammation and the Host Response Glue Grant. Determination of burn patient outcome by large-scale quantitative discovery proteomics. Crit Care Med. 2013 Jun;41(6):1421-34.

282. Miller TM, Pestronk A, David W, Rothstein J, Simpson E, Appel SH, Andres PL, Mahoney K, Allred P, Alexander K, Ostrow LW, Schoenfeld D, Macklin EA, Norris DA, Manousakis G, Crisp M, Smith R, Bennett CF, Bishop KM, Cudkowicz ME. An antisense oligonucleotide against SOD1 delivered intrathecally for patients with SOD1 familial amyotrophic lateral sclerosis: a phase 1, randomised, first-in-man study. Lancet Neurol. 2013 Mar 28.

283. Berry JD, Shefner JM, Conwit R, Schoenfeld D, Keroack M, Felsenstein D, Krivickas L, David WS, Vriesendorp F, Pestronk A, Caress JB, Katz J, Simpson E,Rosenfeld J, Pascuzzi R, Glass J, Rezania K, Rothstein JD, Greenblatt DJ, Cudkowicz ME; Northeast ALS Consortium. Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis. PLoS One. 2013 Apr 17;8(4):e61177 Print 2013.

284. Truong QA, Hayden D, Woodard PK, Kirby R, Chou ET, Nagurney JT, Wiviott SD, Fleg JL, Schoenfeld DA, Udelson JE, Hoffmann U. Sex differences in the effectiveness of early coronary computed tomographic angiography compared with standard emergency department evaluation for acute chest pain: the rule-out myocardial infarction with Computer-Assisted

Schoenfeld, David A., Ph.D. (continued)

25

Tomography (ROMICAT)-II Trial. Circulation. 2013 Jun 25;127(25):2494-502. Epub 2013 May 17.

285. Zhou JY, Krovvidi RK, Gao Y, Gao H, Petritis BO, De AK, Miller-Graziano CL, Bankey PE,Petyuk VA, Nicora CD, Clauss TR, Moore RJ, Shi T, Brown JN, Kaushal A, Xiao W, Davis RW, Maier RV, Tompkins RG, Qian WJ, Camp DG 2nd, Smith RD; Inflammation and the Host Response to Injury Large Scale Collaborative Research Program. Trauma-associated human neutrophil alterations revealed by comparative proteomics profiling. Proteomics Clin Appl. 2013 Aug;7(7-8):571-83.. Epub 2013 May 22. PMCID:PMC3737403

286. Bredella MA, Gerweck AV, Lin E, Landa MG, Torriani M, Schoenfeld DA, Hemphill LC, Miller KK. Effects of GH on body composition and cardiovascular risk markers in young men with abdominal obesity. J Clin Endocrinol Metab. 2013 Jul 3. [Epub ahead of print]

287. Greer DM, Yang J, Scripko PD, Sims JR, Cash S, Wu O, Hafler JP, Schoenfeld DA, Furie KL. Clinical examination for prognostication in comatose cardiac arrest patients. Resuscitation 2013 Nov; 84 (11):1546-51.

288. Lee S, Yamada Y, Tonsho M, Boskovic S, Nadazdin O, Schoenfeld D, Cappetta K, Atif M,Smith RN, Cosimi AB, Benichou G, Kawai T. Alefacept promotes immunosuppression-free renal allograft survival in nonhuman primates via depletion of recipient memory T cells. Am J Transplant. 2013 Dec;13(12):3223-9. Epub 2013 Oct 24.

289. Schuetz C, Dong N, Smoot E, Elias N, Schoenfeld DA, Markmann JF, Yeh H. HCC patients suffer less from geographic differences in organ availability. Am J Transplant. 2013 Nov;13(11):2989-95.. Epub 2013 Sep 6. PMCID:PMC3833452

290. Needham DM1, Dinglas VD, Morris PE, Jackson JC, Hough CL, Mendez-Tellez PA,Wozniak AW, Colantuoni E, Ely EW, Rice TW, Hopkins RO; NIH NHLBI ARDS Network. Physical and cognitive performance of patients with acute lung injury 1 year after initial trophic versus full enteral feeding. EDEN trial follow-up. Am J Respir Crit Care Med. 2013 Sep 1;188(5):567-76.. PMCID:PMC3827703

291. Evins AE, Cather C, Pratt SA, Pachas GN, Hoeppner SS, Goff DC, Achtyes ED, Ayer D, Schoenfeld DA. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014 Jan 8;311(2):145-54. doi: 10.1001/jama.2013.285113.

292. Nierenberg AA, Sylvia LG, Leon AC, Reilly-Harrington NA, Shesler LW, McElroy SL,Friedman ES, Thase ME, Shelton RC, Bowden CL, Tohen M, Singh V, Deckersbach T,Ketter TA, Kocsis JH, McInnis MG, Schoenfeld D, Bobo WV, Calabrese JR; Bipolar CHOICE Study Group. Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder. Clin Trials. 2014 Feb;11(1):114-27. Epub 2013 Dec 17.

293. Roh S, Hoeppner SS, Schoenfeld D, Fullerton CA, Stoeckel LE, Evins AE. Acute effects of mecamylamine and varenicline on cognitive performance in non-smokers with and without schizophrenia. Psychopharmacology (Berl). 2014 Feb;231(4):765-75. Epub 2013 Oct 11.

294. Nishino M, Mathai SK, Schoenfeld D, Digumarthy SR, Kradin RL. Clinicopathologic features associated with relapse in cryptogenic organizing pneumonia. Hum Pathol. 2014 Feb;45(2):342-51. doi: 10.1016/j.humpath.2013.09.010. Epub 2013 Oct 3

295. Mallidi S, Anbil S, Lee S, Manstein D, Elrington S, Kositratna G, Schoenfeld D, Pogue B, Davis S, Hasan T. Photosensitizer fluorescence and singlet oxygen luminescence as dosimetric predictors of topical 5-aminolevulinic acid photodynamic therapy induced clinical erythema. J. Biomed. Opt. 2014 Feb; 19(2):028001.

296. Zhao Y, Cudkowicz ME, Shefner J, Krivickas L, David WS, Vriesendorp F, Pestronk A,Caress JB, Katz J, Simpson E, Rosenfeld J, Pascuzzi R, Glass J, Rezania K, Harmatz JS,Schoenfeld D, Greenblatt DJ. Systemic Pharmacokinetics and Cerebrospinal Fluid Uptake of Intravenous Ceftriaxone in Patients With Amyotrophic Lateral Sclerosis. J Clin Pharmacol. 2014 Oct;54(10):1180-7. doi: 10.1002/jcph.317. Epub 2014 May 16.

Schoenfeld, David A., Ph.D. (continued)

26

297. Elena Ratti, James Berry, Nazem Atassi, Amy Shui, Douglas Hayden, David Schoenfeld, Hong Yu, Robin Conwit, Jeremy Shefner and Merit Cudkowicz. Predictors of Outcome in Amyotrophic Lateral Sclerosis Neurology April 8, 2014 vol. 82 no. 10 Supplement P2.076

298. Bobo WV, Reilly-Harrington NA, Ketter TA, Brody BD, Kinrys G, Kemp DE, Shelton RC, McElroy SL, Sylvia LG, Kocsis JH, McInnis MG, Friedman ES, Singh V, Tohen M, Bowden CL, Deckersbach T, Calabrese JR, Thase ME, Nierenberg AA, Rabideau DJ, Schoenfeld DA, Faraone SV, Kamali M. Effect of adjunctive benzodiazepines on clinical outcomes in lithium- or quetiapine-treated outpatients with bipolar I or II disorder: Results from the Bipolar CHOICE trial. J Affect Disord. 2014 Jun;161:30-5.

299. Klein MB, Goverman J, Hayden DL, Fagan SP, McDonald-Smith GP, Alexander AK,Gamelli RL, Gibran NS, Finnerty CC, Jeschke MG, Arnoldo B, Wispelwey B, Mindrinos MN,Xiao W, Honari SE, Mason PH, Schoenfeld DA, Herndon DN, Tompkins RG; Inflammation and Host Response to Injury, and Large-Scale Collaborative Research Program. Benchmarking outcomes in the critically injured burn patient. Ann Surg. 2014 May;259(5):833-41.

300. Borba CPC, Fekadu A, Teferra S, Bekele D, Shibre T, Oppenheim CE, Schoenfeld DA, Henderson DC. A placebo-controlled trial of folate with B12 in patients with schizophrenia with residual symptoms in Ethiopia using a sequential parallel comparison design. British Journal of Medicine and Medical ISSN: 2231-0614,Vol: 4 (23)

301. Rabideau DJ, Nierenberg AA, Sylvia LG, Friedman ES, Bowden CL, Thase ME, Ketter TA, Ostacher MJ, Reilly-Harrington N, Iosifescu DV, Calabrese JR, Leon AC, Schoenfeld DA. A novel application of the Intent to Attend assessment to reduce bias due to missing data in a randomized controlled clinical trial. Clin Trials. 2014 May 28. pii: 1740774514531096. [Epub ahead of print]

302. Richard Smith, Gary Pattee, Erik Pioro and David Schoenfeld Assessment of Bulbar Function in ALS Clinical Trials (P7.098) Neurology April 8, 2014 vol. 82 no. 10 Supplement P7.098

303. Finkelstein DM, Schoenfeld DA. A joint test for progression and survival with interval-censored data from a cancer clinical trial. Stat Med. 2014 May 30;33(12):1981-9. doi: 10.1002/sim.6096. Epub 2014 Feb 6.

304. Gao, B., Moore, C., Porcheray, F., Rong, C., Abidoglu, C., DeVito, J., Paine, R., Girouard, T. C., Saidman, S. L., Schoenfeld, D., Levin, B., Wong, W., Elias, N., Schuetz, C., Rosales, I., Fu, Y. and Zorn, E. (2014), Pretransplant IgG Reactivity to Apoptotic Cells Correlates With Late kidney Allograft Loss. American Journal of Transplantation, 14: 1581–1591.

305. National Heart, Lung, and Blood Institute ARDS Clinical Trials Network, Truwit JD, Bernard GR, Steingrub J, Matthay MA, Liu KD, Albertson TE, Brower RG, Shanholtz C, Rock P, Douglas IS, deBoisblanc BP, Hough CL, Hite RD, Thompson BT. Rosuvastatin for sepsis-associated acute respiratory distress syndrome. N Engl J Med. 2014 Jun 5;370(23):2191-200. Epub 2014 May 18.

306. Atassi N, Berry J, Shui A, Zach N, Sherman A, Sinani E, Walker J, Katsovskiy I, Schoenfeld D, Cudkowicz M, Leitner M. The PRO-ACT database: design, initial analyses, and predictive features. Neurology. 2014 Nov 4;83(19):1719-25. doi: 10.1212/WNL.0000000000000951. Epub 2014 Oct 8. PMCID: PMC4239834

307. Cudkowicz ME, Titus S, Kearney M, Yu H, Sherman A, Schoenfeld D, Hayden D, Shui A, Brooks B, Conwit R, Felsenstein D, Greenblatt DJ, Keroack M, Kissel JT, Miller R, Rosenfeld J, Rothstein JD, Simpson E, Tolkoff-Rubin N, Zinman L, Shefner JM; Ceftriaxone Study Investigators. Safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis: a multi-stage, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 Nov;13(11):1083-91. doi: 10.1016/S1474-4422(14)70222-4. Epub 2014 Oct 5. PMCID: PMC4216315

308. Beitler JR, Schoenfeld DA, Thompson BT. Preventing ARDS: progress, promise, and pitfalls. Chest. 2014 Oct;146(4):1102-13. doi: 10.1378/chest.14-0555. PMCID: PMC4188145

309. Schoenfeld D. Optimizing phase II clinical trials: novel trial designs. J Peripher Nerv Syst. 2014 Oct;19 Suppl 2:S18-20. doi: 10.1111/jns.12081_3.

Schoenfeld, David A., Ph.D. (continued)

27

310. Zhao Y, Cudkowicz ME, Shefner JM, Krivickas L, David WS, Vriesendorp F, Pestronk A, Caress JB, Katz J, Simpson E, Rosenfeld J, Pascuzzi R, Glass J, Rezania K, Harmatz JS, Schoenfeld D, Greenblatt DJ. Systemic pharmacokinetics and cerebrospinal fluid uptake of intravenous ceftriaxone in patients with amyotrophic lateral sclerosis. J Clin Pharmacol. 2014 Oct;54(10):1180-7. doi: 10.1002/jcph.317. Epub 2014 May 16. Erratum in: J Clin Pharmacol. 2014 Nov;54(11):1320. PMCID: PMC4352577

311. Küffner R, Zach N, Norel R, Hawe J, Schoenfeld D, Wang L, Li G, Fang L, Mackey L, Hardiman O, Cudkowicz M, Sherman A, Ertaylan G, Grosse-Wentrup M, Hothorn T, van Ligtenberg J, Macke JH, Meyer T, Schölkopf B, Tran L, Vaughan R, Stolovitzky G, Leitner ML. Crowdsourced analysis of clinical trial data to predict amyotrophic lateral sclerosis progression. Nat Biotechnol. 2015 Jan;33(1):51-7. doi: 10.1038/nbt.3051. Epub 2014 Nov 2.

312. Yamada Y, Ochiai T, Boskovic S, Nadazdin O, Oura T, Schoenfeld D, Cappetta K, Smith RN, Colvin RB, Madsen JC, Sachs DH, Benichou G, Cosimi AB, Kawai T. Use of CTLA4Ig for induction of mixed chimerism and renal allograft tolerance in nonhuman primates. Am J Transplant. 2014 Dec;14(12):2704-12. doi: 10.1111/ajt.12936. Epub 2014 Nov 13. PMCID: PMC4236265 [Available on 2015-12-01]

313. Januzzi JL, Sharma U, Zakroysky P, Truong QA, Woodard PK, Pope JH, Hauser T, Mayrhofer T, Nagurney JT, Schoenfeld D, Peacock WF, Fleg JL, Wiviott S, Pang PS, Udelson J, Hoffmann U. Sensitive troponin assays in patients with suspected acute coronary syndrome: Results from the multicenter rule out myocardial infarction using computer assisted tomography II trial. Am Heart J. 2015 Apr;169(4):572-8.e1. doi: 10.1016/j.ahj.2014.12.023. Epub 2015 Jan 9. PMCID: PMC4380232 [Available on 2016-04-01]

314. Wang R, Schoenfeld DA, Hoeppner B, Evins AE.Detecting treatment-covariate interactions using permutation methods. Stat Med. 2015 May 30;34(12):2035-47. doi: 10.1002/sim.6457. Epub 2015 Mar 2. PMCID: PMC4420688 [Available on 2016-05-30]

315. Ramchandani R, Finkelstein DM, Schoenfeld DA.A model-informed rank test for right-censored data with intermediate states Stat Med. 2015 Apr 30;34(9):1454-66. doi: 10.1002/sim.6417. Epub 2015 Jan 13. PMCID: PMC4390437 [Available on 2016-04-30]

316. Mallidi S, Watanabe K, Timerman D, Schoenfeld D, Hasan T.Prediction of tumor recurrence and therapy monitoring using ultrasound-guided photoacoustic imaging. Theranostics. 2015 Jan 1;5(3):289-301. doi: 10.7150/thno.10155. eCollection 2015. PMCID: PMC4279192

317. Bobo WV, Reilly-Harrington NA, Ketter TA, Brody BD, Kinrys G, Kemp DE, Shelton RC, McElroy SL, Sylvia LG, Kocsis JH, McInnis MG, Friedman ES, Singh V, Tohen M, Bowden CL, Deckersbach T, Calabrese JR, Thase ME, Nierenberg AA, Rabideau DJ, Schoenfeld DA, Faraone SV, Kamali M. Complexity of illness and adjunctive benzodiazepine use in outpatients with bipolar I or II disorder: results from the Bipolar CHOICE study. J Clin Psychopharmacol. 2015 Feb;35(1):68-74. doi: 10.1097/JCP.0000000000000257.

318. Grissom CK, Hirshberg EL, Dickerson JB, Brown SM, Lanspa MJ, Liu KD, Schoenfeld D, Tidswell M, Hite RD, Rock P, Miller RR 3rd, Morris AH; National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome* Crit Care Med. 2015 Feb;43(2):288-95. doi: 10.1097/CCM.0000000000000715.

319. Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

Schoenfeld, David A., Ph.D. (continued)

28

320. Pursnani A, Chou ET, Zakroysky P, Deaño RC, Mamuya WS, Woodard PK, Nagurney JT, Fleg JL, Lee H, Schoenfeld D, Udelson JE, Hoffmann U, Truong QA. Use of coronary artery calcium scanning beyond coronary computed tomographic angiography in the emergency department evaluation for acute chest pain: the ROMICAT II trial. Circ Cardiovasc Imaging. 2015 Mar;8(3). pii: e002225. doi: 10.1161/CIRCIMAGING.114.002225. Epub 2015 Feb 20. PMCID: PMC4340089 [Available on 2016-03-01

321. Paganoni S, Hyman T, Shui A, Allred P, Harms M, Liu J, Maragakis N, Schoenfeld D, Yu H, Atassi N, Cudkowicz M, Miller TM. Pre-morbid type 2 diabetes mellitus is not a prognostic factor in amyotrophic lateral sclerosis. Muscle Nerve. 2015 Sep;52(3):339-43. doi: 10.1002/mus.24688. Epub 2015 Jun 1. PMCID: PMC4536144

322. Lawson EA, Marengi DA, DeSanti RL, Holmes TM, Schoenfeld DA, Tolley CJ. Oxytocin reduces caloric intake in men. Obesity (Silver Spring). 2015 May;23(5):950-6. doi: 10.1002/oby.21069. Epub 2015 Apr 10. PMCID: PMC4414748 [Available on 2016-05-01

323. Adler JT, Dong N, Markmann JF, Schoenfeld D, Yeh H.Role of Patient Factors and Practice Patterns in Determining Access to Liver Waitlist. Am J Transplant. 2015 Jul;15(7):1836-42. doi: 10.1111/ajt.13301. Epub 2015 Apr 30.

324. Paganoni, Sabrina, et al. "PRE-MORBID TYPE 2 DIABETES MELLITUS AS A PROGNOSTIC FACTOR IN AMYOTROPHIC LATERAL SCLEROSIS REPLY." MUSCLE & NERVE 52.4 (2015): 691-691.

325. Brown, Samuel M.; Grissom, Colin K.; Moss, Marc; Rice, Todd W.; Schoenfeld, David. Non-linear imputation of PaO 2/FIO 2 from SpO 2/FIO 2 among patients with Acute Respiratory Distress Syndrome. Chest (Formerly: Diseases of the Chest). American College of Chest Physicians. 2016 Jan 03. Doi: 10.1016/j.chest.2016.01.003

326. Bryan Q Spring, R Bryan Sears, Lei Zak Zheng, Zhiming Mai, Reika Watanabe, Margaret E Sherwood, David A Schoenfeld, Brian W Pogue, Stephen P Pereira, Elizabeth Villa, Tayyaba Hasan. “A photoactivable multi-inhibitor nanoliposome for tumor control and simultaneous inhibition treatment escape pathways. Nature Nanotechnology. Nature Publishing Group. 2016 Jan. 18. doi:10.1038/nnano.2015.311

327. Ritesch Ramchandani, David A Schoenfeld, Dianne M Finkelstein. Global rank tests for multiple, possibly censored, outcomes. Biometrics. 2016 Jan. 01. DOI: 10.1111/biom.12475

328. Scott Evans, Dean Follmann, David Schoenfeld, Vance G Fowler, Henry F Chambers. Response to Phillips et al. Clinical Infectious Diseases. Oxford University Press. 2015 Dec. 09. civ1003. doi: 10.1093/cid/civ1003

329. Richard S Bedlack, Timothy Vaughan, Paul Wicks, Jamie Heywood, Ervin Sinani, Roger Selsov, Eric A Macklin, David Schoenfeld, Merit Cudkowicz, Alex Sherman. How common are ALS plateaus and reversals. Neurology. Lippincott Williams & Wilkins. 2015 Dec. 9. doi: 10.1212/WNL. 0000000000002251.

330. Hsu JJ, Finkelstein DM, Schoenfeld DA (2015) Outcome-Driven Cluster Analysis with Application to Microarray Data. PLoS ONE 10(11): e0141874. . doi: 10.1371/journal.pone.0141874

331. The Acute Respiratory Distress Syndrome Network. Ventilation with Lower Tidal Volumes as Compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000; 342:1301-1308 2015 Jul. 12. DOI: 10.1056/NEJM20000504342180171/journal.pone.0141874

332. Scott R Evans, Daniel Rubin, Dean Follmann, Gene Pennello, W Charles Huskins, John H Powers, David Schoenfeld, Christy Chuang-Stein, Sara E Cosgrove, Vance G Fowler, Ebbing

Schoenfeld, David A., Ph.D. (continued)

29

Lautenbach, Henry F Chambers. Desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR). Clinical Infectious Diseases 61(5). Oxford University Press. 2015 Sept. 01. doi: 10.1093/cid/civ495

333. Truong QA, Schulman-Marcus J, Zakroysky P, Chou ET, Nagurney JT, Fleg JL, Schoenfeld DA, Udelson JE, Hoffmann U, Woodard PK. “Coronary CT Angiography versus Standard Emergency Department Evaluation for Acute Chest Pain and Diabetic Patients: Is There Benefit with Early Coronary CT Angiography? Results of the Randomized Comparative Effectiveness ROMICAT II Trial.” J Am Heart Assoc. 2016 Mar 22;5(3):e003137. doi: 10.1161/JAHA.115.003137.

334. Overdyk FJ, Dowling O, Newman S, Glatt D, Chester M, Armellino D, Cole B, Landis GS, Schoenfeld D, DiCapua JF. Remote video auditing with real-time feedback in an academic surgical suite improves safety and efficiency metrics: a cluster randomised study. BMJ quality & safety. 2015 Dec 11:bmjqs-2015. doi:10.1136/bmjqs-2015-004226

335. Schoenfeld D. Characterizing the Mechanism of Tumor Suppression by PBRM1 in Clear Cell Renal Cell Carcinoma (Doctoral dissertation, COLUMBIA UNIVERSITY).

336. Schoenfeld DA, Finkelstein DM. Assessing survival benefit when treatment delays disease progression. Clinical Trials. 2016 Jun 1;13(3):352-7. doi: 10.1177/1740774515625990

337. Nicholson K, Haley K, Cornacchio S, Lashgari G, Scalia J, Schoenfeld D, Berry J, Atassi N. Predictive Factors of Survival and Disease Progression After Gastrostomy Tube Placement in ALS: An Interim Analysis (P3. 187). Neurology. 2016 Apr 5;86(16 Supplement):P3-187.

338. Shefner JM, Liu D, Leitner ML, Schoenfeld D, Johns DR, Ferguson T, Cudkowicz M. Quantitative strength testing in ALS clinical trials. Neurology. 2016 Aug 9;87(6):617-24. doi: 10.1212/WNL.0000000000002941

339. Hotta K, Aoyama A, Oura T, Yamada Y, Tonsho M, Huh KH, Kawai K, Schoenfeld D, Allan JS, Madsen JC, Benichou G. Induced regulatory T cells in allograft tolerance via transient mixed chimerism. JCI insight. 2016 Jul 7;1(10). DOI:10.1172/jci.insight.86419

340. David Schoenfeld, William Su, Sakellarios Zairis, Deepti Mathur, Raul Rabadan, Ramon Parsons. PBRM1 alteration in clear cell renal cell carcinoma increases tumorigenicity through ALDH1A1 upregulation. [abstract]. In: Proceedings of the AACR Special Conference on Chromatin and Epigenetics in Cancer; Sep 24-27, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2016;76(2 Suppl):Abstract nr A24.

341. Nierenberg AA, McElroy SL, Friedman ES, Ketter TA, Shelton RC, Deckersbach T, McInnis MG, Bowden CL, Tohen M, Kocsis JH, Calabrese JR, Kinrys G, Bobo WV, Singh V, Kamali M, Kemp D, Brody B, Reilly-Harrington NA, Sylvia LG, Shesler LW, Bernstein EE, Schoenfeld D, Rabideau DJ, Leon AC, Faraone S, Thase ME. Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness): a pragmatic 6-month trial of lithium versus quetiapine for bipolar disorder. J clin Psychiatry. 2016 Jan: 77(1):90-9 doi: 10.4088/JCP.14m09349.

Proceedings of Meetings

1. Evans A, Anderson J, Chang C, Jenkin D, Kramer S, Schoenfeld D, Wilson C. Adjuvant chemotherapy for meduloblastoma and ependymoma. Proceedings of the symposium on multidisciplinary aspects of brain tumor therapy. 1979; 219-222.

2. Schoenfeld DA. An estimate of the survival benefit of chemotherapy of advanced head and neck

cancer and its implication to the design of clinical trials. In: Chretien PB, Johns ME, Shedd DT, Strong EW, Ward PH, eds, Proceedings of the international conference on head and neck cancer, Baltimore, Maryland 1984. Philadelphia: B.C. Decker, Inc. 1984; 78-83.

3. Vogl SE, Schoenfeld DA. Is partial response of value in the chemotherapy of advanced head and

neck cancer? In: Chretien PB, Johns ME, Shedd DT, Strong EW, Ward PH, eds, Proceedings of

Schoenfeld, David A., Ph.D. (continued)

30

the international conference on head and neck cancer, Baltimore, Maryland 1984. Philadelphia: B.C. Decker, Inc. 1984; 404-406.

4. Schoenfeld DA. Animal experiments and clinical trials. Proceedings of the American

Association of Physicists in Medicine first mid year symposium on multiple regression analysis, Medical Physics Monograph No. 13, American Institute of Physics, New York. 1986; 132-145.

5. Growdon JH, Ghika J, Tennis M, Cole DG, and Schoenfeld D. Noradrenergic mechanisms in

progressive supranuclear palsy, In norepinephrine deficiency, Narabayashi and Mizuno eds. Proceedings of a satellite symposium 10th int. symposium on Parkinson’s disease Tokyo. 1991; 27-30 , The Parthenon Publishing Group, New York

6. Efird J, Pardo P, Okuieff D, Schoenfeld D, Aronen H. Principles of logistic regression in

radiation oncology. Proc of the Fifth Annual SAS Users Group Conference, Baltimore. 1992; 444-453.

7. Schoenfeld D. Using SAS SQL and LateX to create automatically regenerating statistical reports.

Proc of the Fifth Annual SAS Users Group Conference, Baltimore. 1992; 475-488. Reviews, Chapters, and Editorials 1. Cunningham T, Schoenfeld D, Nathanson L, Wolter J, Patterson WB, Cohen M. A controlled study

of adjuvant therapy in patients with Stage I and II malignant melanoma. In: Terry WE, Windhorst D eds. Immunotherapy of Cancer: Present Status of Trials in Man. New York: Raven Press. 1977:19-26.

2. Cunningham TJ, Schoenfeld D, Nathanson L, Wolter J, Patterson W, Cohen M, Kupermic M,

Carbone PP. A controlled ECOG study of adjuvant therapy in patients with stage I and II malignant melanoma. In: Jones SE, Salmon SE, eds Adjuvant Therapy of Cancer II. New York: Grune & Stratton. 1979.

3. Kallman R, Combs C, Franko A, Furlong B, Kelley S, Kemper H, Miller R, Rapaccietta D,

Schoenfeld D, Takahashi M. Evidence for the recruitment of non-cycling clonogenic tumor cells. In: Meyn RE, Withers HR, eds Radiation Biology in Cancer Research. New York: Raven Press. 1980:397-414

4. Solomon J, Schoenfeld D. The uterotrophic effect of Delta-9 THC in ovariectomized rats and mice.

Res Comm in Chem Path and Pharm. 1980; 29:603-611. 5. Schoenfeld D. Book Review: The statistical analysis of failure time data by JD Kalbfleisch and RL

Prentice. The American Scientist. 1981; 69:684. 6. Nelson J, Schoenfeld D, Tsukada Y, Fulling K. Histologic criteria with prognostic significance for

malignant glioma. In: Chang Chu H, ed Tumors of the central nervous system: modern radiotherapy in multidisciplinary management. New York: Masson Publishing Company. 1982; 1-4.

7. Horton J, Schoenfeld D. Chemotherapy for malignant gliomas. In: Chang Chu H, ed. Tumors of the

central nervous system, modern radiotherapy in multidisciplinary management. New York: Masson Publishing Company. 1982; 47-56.

8. Cunningham TJ, Schoenfeld D, Nathanson L, Wolter JM, Patterson WB, Borden EC. A controlled

ECOG study of adjuvant therapy (BCG, BCG-DTIC) in patients with stage I and II malignant

Schoenfeld, David A., Ph.D. (continued)

31

melanoma. In: Terry WD, Rosenberg, SA, eds Immunotherapy of human cancer. New York: Elsevier North Holland, Inc. 1982; 271-277.

9. Schoenfeld D. Analysis of categorical data: logistic models. In: Mike V, Stanley K, eds, Statistics in

medical research: methods and issues with applications to clinical oncology New York: John Wiley and Sons. 1983.

10. LeBlanc GA, Schoenfeld DA, Surprenant DC. The effects of food concentration animal interactions

and water volume on survival growth and reproduction of daphnia magna under flow through conditions. In: Bishop, Cardwell, and Heidolph, eds, Aquatic toxicity and hazard assessment ASTM publication and 04-802000-16, Philadelphia. 1983.

10. Gelber R, Lavin P, Mehta C, Schoenfeld DA. Statistical methods of aquatic toxicology. In: Rand GM, Petrocelli SR, eds Concepts in aquatic toxicology. New York: Hemisphere Publishing. 1985; 110-123.

11. Nelson DF, Diener-West M, Horton J, Chang CH, Schoenfeld D, Nelson JS. Combined modality

approach to treatment of malignant gliomas--re-evaluation of RTOG 7401/ECOG 1374 with long-term follow-up: a joint study of the radiation therapy oncology group and the eastern cooper. NCI Monograph. 1988; 6:279-284.

12. Schoenfeld DA. Issues in the testing of drug combinations. Journal of AIDS 1990; 3: S104-S107. 13. WHO expert committee on cancer pain relief and active supportive care, cancer pain relief and

palliativen care. Technical Report Series 804, WHO Geneva. 1990. 14. Darbyshire J, Schoenfeld DA, Weller IV. Clinical trials in HIV infection: current problems and

future directions. AIDS. 1991; 5: S167-S174. 15. Ellenberg SS, Finkelstein DM, Schoenfeld DA. Statistical issues arising in AIDS clinical trials. J

Am Stat Assoc. 1992; 87:562-568. 16. Shah A, Schoenfeld DA, De Gruttola V. Risk estimation using a surrogate marker measured with

error (STMA V37 3666). Statistical Modeling. Proceedings of the 10th International Workshop on Statistical Modeling. Lecture Notes in Statistics. 1995; 104: 267-275.

17. Wheeler A, Bernard GR, Schoenfeld D, Steinberg K. Methylprednisolone for unresolving ARDS.

JAMA. 1998 Dec 23-30; 280(4):2074-2074. 18. Schoenfeld D. Book Review: Design and Analysis of Clinical Trials (Concepts and Methodologies).

Wiley Series in Probability and Statistics, 1998. 19. Schoenfeld DA with Wahl M. The Overworked Teens and the Tokyo Survivors. The MDA/ALS

Newsletter. Oct. 2003; 8(10):2-3. 20. Schoenfeld DA with Wahl M. Cluster or Clutter? The MDA/ALS Newsletter. Nov. 2003; 8(11):9. 21. Schoenfeld DA with Wahl M. It’s Different—But is it ‘Significant’? The MDA/ALS Newsletter.

Dec. 2003; 8(12):11 22. Cudkowicz ME. Schoenfeld D. Williams L. Improving the responsiveness of rating scales: the

challenge of stepping twice into the same river. Neurology. 2004 May 25; 62(10):1666-7.

Schoenfeld, David A., Ph.D. (continued)

32

23. Schoenfeld DA, Meade MO. Pro/con clinical debate: It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility. Critical Care. 2005 Feb; 9(1):34-36; discussion 34-6.

24. Henderson DC, Copeland PM, Borba CP, Daley TB, Nguyen DD, Cagliero E, Evins AE, Zhang H ,

Hayden D, Freudenreich O, Cather C, Schoenfeld D, Goff DC. Glucose metabolism in patients with schizophrenia treated with olanzapine or quetiapine: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry. 2005 Jan; 62(1):19-28.

25. Schoenfeld D. Survival methods, including those using competing risk analysis, are not appropriate

for intensive care unit outcome studies. Critical Care; 2006: 10(1): 103. Books, Monographs, and Text Books

Finkelstein DM, Schoenfeld DA. eds. AIDS clinical trials: Guidelines for design and analysis. New York: John Wiley & Sons. 1995

Thesis

Properties of the Orthogonal Components of the Cramer-Von-Mises Statistic University of Oregon 1974 Non-print Materials Statistical considerations for clinical Trials and Scientific Experiments Web site that computes sample size. http://hedwig.mgh.harvard.edu/size.html Contributions to the Comprehensive R Archive Network, CRAN Seqmon: Program for computing sequential boundaries in CRAN Pssm: Program for calculation of a sensitivity analysis of using time to progression to infer improvements in survival Supcluster: Program for supervised cluster analysis Power and Sample Size Calculation for Logistic and Cox Models http://hedwig.mgh.harvard.edu/biostatistics/node/41 A program to calculate the power or sample size for a random slopes model http://hedwig.mgh.harvard.edu/biostatistics/node/42 A power calculator for the Sequential Parallel Design http://hedwig.mgh.harvard.edu/biostatistics/node/43 A calculator of the effects of missing-modeling a proportional hazards model http://hedwig.mgh.harvard.edu/biostatistics/node/45