Transcript EFFECTS OF CPAP IN ADULTS (ATS statement)

Clinical & Translational
Research Center
(CTRC)
Clinical & Translational Science Award
(CTSA)
Structure of the Penn CTSA
Translational
Biomedical
Imaging Center (TBIT)
Biomedical Informatics
In Translation (BIIT)
Clinical and
Translational
Research Center
(CTRC)
Chemical Biology
In Translation (CBIT)
Personalized Medicine
in Translation (PERMIT)
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
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
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
CTRC administration
Active CTRC protocols
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234
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150
100
50
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PENN
CHOP
No. of protocols by CHOP division
GI/Nutrition
Endocrinology
Nephrology
Hematology
Neonatology
Oncology
Neurology
Rheumatology
Pulmonary
Cardiology
Surgery
Allergy/ID
Adolescent
Rehab
Psychology
ICU/anesthesi
Psychiatry
Nursing
Pharmacology
Genetics
Gen Peds
0
5
10
15
20
25
30
35
No. of protocols by Penn division
Phamacology
Oncology
Psychiatry
Sleep
Nephrology
Neurology
Pulmonary
Infectious
Cardiology
Epidemiology
Endocrinology
Radiology
Radiation Onc
OB/GYN
GI
Anesthesia
Surgery
Rheumatology
Monell
Geriatrics
Dermatology
Nephrology
Nursing
Psychology
Internal Medicine
0
5
10
15
20
25
Clinical Research Space
(CHOP)
Inpatient: 5 West
• 4 beds
Outpatient: Main & 3550
•4 exam rooms
•6 chairs
•Consultation rooms
•Lab processing
Research Nursing
Research Nursing (CHOP)
(Dr. Medoff-Cooper)
• Nursing services:
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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
Scatterbed Nurses
• ICUs
• OR
• ED
• Clinics
• Sleep lab
• etc.
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)
Research nursing (PENN)
• Unit is open 24/7
• 16 nurses trained in research nursing
• 1 nurse practitioner
CTSA cores
• Equipment
• Personnel
• Scientific and technical oversight
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)
Nutrition Core
Babette Zemel, PhD
Nutrition Laboratory
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Anthropometrics & growth
Body composition (BodPod, DXA)
Resting energy expenditure
Bone density, growth (DXA, pQCT,
knee height)
• Muscle strength
Bionutrition Research Unit
(Dr. Compher)
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Analyze diet records
Nutrition education / consult
Plan study meals
Design & test recipes
Provide special diets
(metabolic kitchen)
Cardiovascular Core
Emile Mohler, MD & Meryl Cohen, MD
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
Pediatric tests
• Echo (with or without sedation)
• EKG
Pulmonary Core
Hank Mayer, MD
Pulmonary Core
• PFTs: Outpatient & inpatient
• Bronchodilator / metacholine
challenges
• Exhaled NO; breath condensates
• Infant PFTs
Behavioral Neuroscience Core
Jerilynn Radcliffe, PhD
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
Sleep Core
Allan Pack, MD PhD, Alex Mason, MD PhD
Sleep Core
• Polysomnography
• Multiple sleep latency tests
• Actigraphy
Investigational Drug Service
K. Rockwell
• Procurement / storage /
dispensing study drugs
• Randomization
• Placebos
• Maintains study randomization
schedule to allow for unblinding
in case of emergency, 24/7
Informatics Core
(E. Escobar)
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
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
Translational Core Laboratory
Charles Stanley MD, Muredoch Reilly MD
TRANSLATIONAL CORE LABORATORIES
Clinical Sites
Pre-Clinical Laboratories
Sample Collection
Sample Collection
Sample Processing
Freezer Storage
TCL Bioinformatics
Molecular Biology Core
DERC RIA Biomarker Core
Lipid/CV Biomarker Lab
Pathology BioResources
Biochemistry Core
Novel Bioassay
Development
BIIT
Cell Biology Core
Proteomic Core
Lipidomic Core
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
Translational Core Laboratory
Molecular Markers
•DNA sequencing/Re-sequencing/Mutation detection
•Sequencing prep Data analysis
•TaqMan SNP genotyping
•Microsatellite marker/LOH analysis/Fragment analysis
•Real-time TaqMan PCR Gene Expression Analysis
•PCR/Gel Analysis/Primer Design
Establishment of EBV transformed cell lines from
fresh or frozen PBMCs
How do I apply?
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
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
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 
GRANTS
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
JIPGP recipients 2010
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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
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
http://www.itmat.upenn.edu/ctrc/i
ndex.shtml