Affiliate NetworksComprehensive Cancer Center Perspective

Michael Benedict, PharmDVice President, ResearchMoffitt Cancer Center

Today

Brief overview of Moffitt History with Affiliates Successes and Challenges

Total Cancer Care Initiative

Partnering with NCCCP sites

Cancer Centers of Florida

Ocala Oncology

Broward General Med. Ctr.

Baptist Hospital of Miami

North Broward Med. Ctr.

Martin Memorial Hospital

CCC&R/Watson Clinic

Bethesda Memorial Hosp.

Tallahassee Memorial

Morton Plant Mease

Women’s Cancer Assoc.

St. Joe’s Candler, Savannah

Space Coast Med. Assoc.

Southeast Nebraska Cancer Ctr.

Sarasota Memorial Hospital

Leesburg Regional Med. Ctr.

Florida GYN Oncology

St. Joseph’s Hospital - Tampa

Boca Raton Com. Hosp.

Carolinas Medical Center

Greenville Hospital System

Hartford Hospital

Our Lady of the Lake

St. Vincents of Indiana

Billings Cancer Center

Total Cancer Care

SEP2C

Cooperative Group

National Cancer Institute

James A. Haley VA

Klinik Lowenstein, Germany

Duke University

Jefferson Medical College

Louisiana State Univ.

Mayo Clinic, Jacksonville

Univ. of Chicago

Johns Hopkins Univ.

Emory University

Univ. of Florida - Gainesville

Ponce School of Med.

Fox Chase Cancer Center

Virginia Commonwealth Univ.

Medical Univ. of SC

Univ. of North Carolina

Vanderbilt University

Cleveland Clinic

Univ. of Louisville

Cornell University

Montefiore Medical Ctr.

Univ. of Maryland

Univ. of FL - Jacksonville

Minneapolis VA

Overton Brooks VA

MCC Clinical Intervention

MCC Prevention

FIQCC

MCC Non Intervention

Project Type

External Research Sites : 2010

The Situation

Only 2-4% of adult cancer patients enrolled in clinical trials Klabunde CN etal JNCI 2011

85% of cancer patients are treated in their local community

Lack of practice standards and quality measurements

Patient centered outcomes research requires community participation

Access to clinical trials, esp. underserved populations is a challenge

Molecularly directed medicine requires new approaches, infrastructure, and connections

Benefits

Expands treatment options for the patient in the community

Patients can be treated close to home decreasing costs of travel and time

Collaboration of institutions may increase referrals for both institutions

Increase market advantage for community

Barriers

Cost - inadequate funding Lack of interesting trials Trial characteristics that may be

difficult to implement in community Extra-biopsy Advanced Imaging

Increased regulatory burden IRB availability or funding Monitoring and oversight

Moffitt History with Affiliates

Program began in 1998 Part of Moffitt State Mandate

Instrumentality of the State Designate “Partner Hospitals”

Export trials Educational opportunities, use of

name/logo: Branding Referrals, marketing advantage

Focus cooperative group trials

Moffitt Clinical Research Network - 2006

Office created to provide oversight and centralization

Protocol review and preparation

Site approval/credentialing

Liaison between Moffitt & site staff

Regulatory, contracting, budget, payment

Assisted with data entry & monitoring

Training resource

Moffitt Clinical Research Network Re-invigoration of the program Identified physician champion Concerted effort to place Investigator Initiated

Trials (IIT) in the community Lot of Interest

Limited success Accrual inconsistent Funding poor Complicated, difficult to implement

Emergence of academic affiliations Project Sunshine N01 – Southeast Phase II Consortium

Total Cancer Care Consortium – M2Gen

– Risk Factors– Genetics– Early Detection– Health Disparities

– Genomics/Proteomics– Imaging Modalities– Nanotechnology

– Molecular Oncology– Biomarker Analysis

– Primary Therapy • Multimodality • Target Based– Post Therapy • Surveillance– Clinical Trials Matching

– Recurrence Therapy– Drug Discovery– Adaptive Trial Design

– Behavioral Research– Psychosocial & Palliative Care– Family Needs– Health Outcomes

– Prevention– Lifestyle/Nutrition– Education

Intervention

Diagnosis

Prognosis

Treatment

Relapsed Disease

Survivorship Populations at Risk

Personalized Approach to a Patient’s Cancer Journey

(http://www.hhs.gov/myhealthcare/news/phc_2008_report.pdf; pg 243)

The Purpose Identify the needs of individual patients; Identify markers that would predict needs and risks

so that interventions could become preemptive; Identify molecular signatures for patients who are

not likely to respond to standard of care; Utilize clinical characteristics and molecular

profiling techniques to match the right patient to the right treatment at the right time the first time;

Raise the standard of care for all patients by integrating new technologies in an evidenced based approach to maximize benefits and reduce costs.

The Approach for Cancer

Can we follow you throughout your lifetime?

Can we study your tumor using molecular technology?

Can we recontact you?

Total Cancer Care Protocol

Unique Consenting Approach

Wireless touch- screen tablet

Connects via secure interface and forwards HIPAA-compliant information to database

Consists of IRB Approved:

Introductory Video

Consent Video by PI

Informed Consent

Signature Capture

Demographics Survey

Electronic Consenting System

Norton Cancer Institute, Louisville, KY

Partners in the Fight Against Cancer

Billings Clinic

Lehigh Valley

Total Cancer Care Research Protocol

TCC protocol active at 18 sites with over 69,871 (1) patients consented Enrolling approx 500 patients/week 9 sites in Florida and 9 sites in other states (NC,

SC, NE, LA, IN, KY, CT, MI, GA)

Tissue biorepository continues to expand with 22,748 (1) tissue samples collected

16,223 (1) tumors profiled

Longitudinal data collection

(1) As of 2/4/11

Productivity TCC Consortium sites led to interests in capitalizing on this network

CCSG Administrative Supplement

Intended to build linkages w NCCCP sites

To better attain collaborative goals in relation to accrual to trials collection of quality biospecimens outreach to underserved populations

Leverage the resources of both initiatives (CCSG – NCCCP)

Due June 2009

CCSG Administrative Supplement

Awarded September 2009 Partners

Billings Clinic Hartford Hospital

Aims Dissemination novel trials – N01 Participation in behavioral and outcomes

research Capitalize on the Biospecimen processes

NCCCP in Clinical Trial Participation

Hartford (3 trials) Phase 2 trial in ovarian cancer Multi-arm Phase 2 trial in OC,

endometrial, HCC, islet cell and carcinoid tumors

Phase 1/2 trial in breast cancer

Billings (5 trials) Phase 2 trial in SCC of H&N Multi-arm Phase 2 trial in OC,

endometrial, HCC, islet cell and carcinoid tumors

Phase 1/2 trial in breast cancer Phase 2 trial in myeloma Phase 1/2 trial of 1-MT/docetaxel in

solid tumors

(NCI CM-62208 N01 Contract: Southeast Phase 2 Consortium)

Clinical Trials Video Evaluation

Internally developed DVD about trials English and Spanish (trans-created) Send to new patients Help to initiate the Dialog about trials Prior to roll out - validation

Health Outcomes and Behavior Program Paul Jacobsen, PhD NCCCP partner participation Completed - Data under review currently

NCCCP Partnering Lessons Learned

Eagerness to participate in research Desire a seat at the table in designing

and conducting research Sophisticated infrastructure in place

which is required to support trials Focused Hub of trial support

● (Clinical Trials Office)

Centralize Infusion Critical mass of existing research

NCCCP Partnering Lessons Learned

Robust Health Information Management systems and willing to invest to linkages

Community practices have unique challenges in conducting Total Cancer Care Protocol Surgical – Medical Oncology Links Integrating protocol into high volume clinical

operations BUT it can be done and DONE WELL

One of the best partners to help us realize personalized cancer care (molecularly directed)

What’s Next

Trial Matching TCC Data

3 NCCCP sites and 2 FL based consortuim members

Identifying trial ready populations●Breast●Ovarian●Lung

What's Next

Capitalize on TCC Network Patient Data

Molecular Information

New Type of

Trial

Streamlining Clinical Trials

Broad Patient Population

Traditional Clinical Trials

Molecularly DefinedPopulation

~Half the patients<Half the time>Response rates

““TurboTrialTurboTrial””

10-12 Years 3-5 Years

Thank you