clinical & translational research center (ctrc)
TRANSCRIPT
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Clinical & Translational Research Center
(CTRC)
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Clinical & Translational Science Award (CTSA)
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Chemical BiologyIn Translation (CBIT)
Chemical BiologyIn Translation (CBIT)
Clinical and Translational
Research Center(CTRC)
Clinical and Translational
Research Center(CTRC)
Personalized Medicinein Translation (PERMIT)Personalized Medicinein Translation (PERMIT)
Biomedical InformaticsIn Translation (BIIT)
Biomedical InformaticsIn Translation (BIIT)
Translational Biomedical
Imaging Center (TBIT)
Translational Biomedical
Imaging Center (TBIT)
Structure of the Penn CTSA
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Transcendant themes of the Penn CTSA
• Translational therapeutics– Promote and facilitate translation of preclinical
studies into proof of concept and mechanistic studies in humans
• Bridging the pediatrics / adult divide
• Education and investment in human capital
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CTRC• Formed in 2006• Joining of 2 previous GCRCs
(PENN 1965, CHOP 1962)• Expanded services, functions and
clinical cores• Competitive renewal phase to start
this July
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CTSA Clinical & Translational Research Center
• Inpatient & outpatient research beds• Clinical cores
– Nutrition, Neurobehavioral, Sleep, Cardiovascular, Pulmonary
• Translational core lab• Informatics support• Biostatistical support• Junior and senior investigator grants
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CTRC administration
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Active CTRC protocols
245 234
0
50
100
150
200
250
CHOPPENN
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No. of protocols by CHOP division
0 5 10 15 20 25 30 35
Gen PedsGenetics
PharmacologyNursing
PsychiatryICU/anesthesi
PsychologyRehab
AdolescentAllergy/ID
SurgeryCardiologyPulmonary
RheumatologyNeurologyOncology
NeonatologyHematologyNephrology
EndocrinologyGI/Nutrition
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No. of protocols by Penn division
0 5 10 15 20 25
Internal MedicinePsychology
NursingNephrology
DermatologyGeriatrics
MonellRheumatology
SurgeryAnesthesia
GIOB/GYN
Radiation OncRadiology
EndocrinologyEpidemiology
CardiologyInfectious
PulmonaryNeurology
NephrologySleep
PsychiatryOncology
Phamacology
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Clinical Research Space(CHOP)
Inpatient: 5 West• 4 beds
Outpatient: Main & 3550•4 exam rooms•6 chairs•Consultation rooms•Lab processing
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Research Nursing
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Research Nursing (CHOP)(Dr. Medoff-Cooper)
• Nursing services:– Phlebotomy / IV infusions– Medication administration– Vital signs– Patient monitoring
• Study specific requirements, e.g. ECGs• Basic laboratory processing / shipping• Space for consenting of study participants,
physical exams, questionnaire administration• Limited Saturday hours offered
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Scatterbed Nurses
• ICUs• OR• ED• Clinics• Sleep lab• etc.
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Clinical research space(PENN)
• HUP (1 Dulles)– Dedicated 8 bed inpatient unit– Outpatient units (5 single rooms; one large room
with 5 chairs) – 2 consultation rooms
• Penn Presbyterian Hospital (Mutch)– Dedicated outpatient unit (2 beds, 4 chairs)
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Research nursing (PENN)
• Unit is open 24/7• 16 nurses trained in research nursing• 1 nurse practitioner
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CTSA cores
• Equipment
• Personnel
• Scientific and technical oversight
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Core design
• Medical and technical directorship• Combined adult / pediatric
components• Research quality control• Charge-back mechanism with low
rates (need to budget into new grant proposals)
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Nutrition Core
Babette Zemel, PhD
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Nutrition Laboratory
• Anthropometrics & growth• Body composition (BodPod, DXA)• Resting energy expenditure• Bone density, growth (DXA, pQCT,
knee height)• Muscle strength
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Bionutrition Research Unit (Dr. Compher)
• Analyze diet records• Nutrition education / consult• Plan study meals• Design & test recipes• Provide special diets
(metabolic kitchen)
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Cardiovascular Core
Emile Mohler, MD & Meryl Cohen, MD
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Vascular studies• Brachial artery reactivity testing• Carotid intimal medial thickness testing• Arterial duplex ultrasound• Venous duplex ultrasound• Ankle-brachial index• Pulse wave velocity• NIRS of skeletal muscle
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Pediatric tests
• Echo (with or without sedation)
• EKG
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Pulmonary Core
Hank Mayer, MD
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Pulmonary Core
• PFTs: Outpatient & inpatient
• Bronchodilator / metacholine challenges
• Exhaled NO; breath condensates
• Infant PFTs
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Behavioral Neuroscience Core
Jerilynn Radcliffe, PhD
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Behavioral Neuroscience Core
• Neuropsychological testing (infancy through adulthood)
• Training and supervision for research assistants to conduct neuropsychological testing
• Consultation on study design, test interpretation, manuscript preparation
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Sleep Core
Allan Pack, MD PhD, Alex Mason, MD PhD
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Sleep Core
• Polysomnography• Multiple sleep latency tests• Actigraphy
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Investigational Drug ServiceK. Rockwell
• Procurement / storage / dispensing study drugs
• Randomization• Placebos• Maintains study randomization
schedule to allow for unblinding in case of emergency, 24/7
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Informatics Core(E. Escobar)
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Informatics Core
• Case report forms (CRF) development• Development and maintenance of databases• Storage of study databases on a secured server• Assistance with proprietary software• New initiatives in conjunction with CTSA BIIT
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Biostatistics Core• Assist with statistical analysis
plans• Power calculations• Help revise protocols after
Council reviews• Data analysis for K23 & JIPGP
recipients, pilot studies
Drs. Cucchiari, Gallagher & Shults
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Translational Core Laboratory
Charles Stanley MD, Muredoch Reilly MD
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TRANSLATIONAL CORE LABORATORIES
Biochemistry CoreMolecular Biology Core Cell Biology Core
Sample Processing
TCL Bioinformatics
Proteomic CoreLipidomic Core
DERC RIA Biomarker CoreLipid/CV Biomarker LabPathology BioResources
Clinical Sites
Sample Collection
Novel Bioassay Development
BIIT
Pre-Clinical Laboratories
Sample Collection
Freezer Storage
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Biochemistry services
• ELISA, RIA, spectrophotometry, SPE, TLC, HPLC, platelet aggregation and function studies
• 69 types of ELISA, enzymatic and RIA assays
• Collection, processing, shipping, storage
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Translational Core LaboratoryMolecular MarkersMolecular Markers
•DNA sequencing/Re-sequencing/Mutation detectionDNA sequencing/Re-sequencing/Mutation detection•Sequencing prep Data analysisSequencing prep Data analysis
•TaqMan SNP genotypingTaqMan SNP genotyping
•Microsatellite marker/LOH analysis/Fragment analysisMicrosatellite marker/LOH analysis/Fragment analysis
•Real-time TaqMan PCR Gene Expression AnalysisReal-time TaqMan PCR Gene Expression Analysis
•PCR/Gel Analysis/Primer DesignPCR/Gel Analysis/Primer Design
Establishment of EBV transformed cell lines from Establishment of EBV transformed cell lines from fresh or frozen PBMCsfresh or frozen PBMCs
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How do I apply?
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Application process (1)
• Joint IRB/CTRC reviews via eIRB
• Answer “Yes” to question asking if you will use the CTRC – links to eCTRC module
• Reciprocity with Penn
• Annual reviews concurrent with IRB reviews
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Application process (2)
• Resources committee meets monthly
• Rapid feedback
• May be asked to present to CTRC Council or Staff meeting
• You MUST acknowledge the CTSA in your publications
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Charge-back mechanism
• Minimal charges to cover actual costs of the study
• Discuss with CTRC before submitting grants
• CTRC provides blurbs to include in your grant budget justifications
• Charges may go up soon
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GRANTS
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Junior Investigator Pilot Grants
• Junior investigators (rank < associate professor)
• Patient oriented research• Primarily pilot studies for generation of
preliminary data for grants• Use of CTRC resources• $20,000 / yr for 1-2 years
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JIPGP recipients 2010• Michelle Denburg, MD,MSCE, Nephrology, Pediatrics
Vitamin D Status in the Setting of Nephrotic-Range Proteinuria
• Sara DeMauro, MD,MSCE, Neonatal-Perinatal, Pediatrics
The Role of Serial Echocardiography to Detect an Asymptomatic Patent Ductus Arteriosus (PDA) in Very Low Birth Weight (VLBW) Infants: A Pilot Randomized Controlled Trial
• Kimberly Lin, MD, Cardiology, Pediatrics
Cardiac biomarkers during anthracycline therapy and the risk of cardiotoxicity
• Frances Balamuth, MD, PhD, Emergency Medicine, Pediatrics
Characterization of Inflammatory Biosignatures in Adolescent Females with Abdominal Pain
• Andrew Calabria, MD, Endocrinology, Pediatrics
Adjunctive Measures of Glycemic Control in Children with Post-prandial Hypoglycemia after Fundoplication
• Michael Grandner, PhD, Center for Sleep and Respiratory Neurobiology, Medicine
Health and Performance Outcomes Associated with Short Sleep Duration
• James Lee, MD, Pulmonary, Allergy, and Critical Care, Medicine
Dietary Antioxidant Therapy for the Prevention of Primary Graft Dysfunction in Lung Transplantation
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CTSA grants
• JIPGP ($20-40,000)• TAPITMAT ($150,000)
– Transdisciplinary awards program in translational medicine and therapeutics)
• TBIC ($25-50,000)– Translational Biomedical Imaging Center)
• CBIT ($15,000)– Chemical Biology in Translation)
• K12
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http://www.itmat.upenn.edu/ctrc/index.shtml