1. Overview of Clinical & Translational Research @ Penn
September
8:00-8:30

2. What do I need to do human research?
Training
Mentor
Vocabulary
Structure/Space
Ideas
Subjects
Datasets
Regulatory
Resource Locator
Protected Time
Statistical Support
Funding
Knowledgelink
Collaborators/Community
Coaching/Writing
Passion
Persistence

3. Mentor Choose well – Knowledgeable Has Time for U Around
OK to have a Team

4. What is Clinical Research?
Clinical Research is Research with human subjects that is:
Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:
mechanisms of human disease
therapeutic interventions
clinical trials
development of new technologies
Epidemiological and behavioral studies.
Outcomes research and health services research.
Studies falling under 45 CFR part (b) (4) (Exemption 4) are not considered clinical research by this definition.

5. What is translational research?5
What is translational research?
“Translational research means different things to different people, but it seems important to almost everyone”
Stephen Woolf, JAMA, 2008
Commonly used terms: clinical research, patient-oriented research, translational research
NIH roadmap: Zerhouni, Science 2003
“Bench to bedside”

6. 6
“the transfer of new understandings of disease mechanisms gained in the laboratory into the development of new methods for diagnosis, therapy, and prevention and their first testing in humans.”
T1 translation
“the translation of results from clinical studies into everyday clinical practice and health decision making.”
T2 translation:
Sung et al., JAMA 2003: Institute of Medicine Clinical Research Roundtable report

7. T3 and T4? T3: Dissemination and implementation research7
T3 and T4?
T3: Dissemination and implementation research
Community-based participatory research
Can occur in “practice-based research networks”
Westfall et al., JAMA 2007
Key questions:
Is a treatment currently being used?
What are gaps in care or barriers to care?
Accuracy or efficacy when implemented in real- world settings?
T4: Public policy research

8. Structure
1 Dulles
PCAM 4 South
PPMC Mutch Building 1st Floor

11. Subjects & Data & Datasets

12. Resource Locator

13. EPIC
CALL
SERVICE

14. Biostatistics
Andrew Cucchiara, PhD
(10:30 – 10:50; STAY
TUNED!)

17. $$$ Funding $$$

18. Intramural Funding

19. Extramural Funding

22. Collaborations – Network - Resources
ITMAT Bioinformatics
Core
Clinical Research Computing Unit (CRCU)
Biostatistics Core
Biochemistry Core Lab
Center for Clinical Epidemiology and Biostatistics (CCEB)
Research Nurse Core
Kinetics Modeling and Simulation (KMAS)
Bionutritional Research Core
Clinical Translational Research Center
(CTRC)
Biomedical Lab
Post-Doctoral Fellow
Investigational Drug Service
Biostatistics,
Bioinformatics,
Pharmacometrics
Animal Facilities
ITMAT Clinical Trials Unit
Human Subject
Protection
Animal Testing
Research
Plan
Basic
Research
Physician-Scientist
Clinical
Research
Research
Plan
Biomedical Mass
Spectrometry
Industry
Administration / Office of Human Research (OHR)
Institutional Animal Care and Use Committee (IACUC)
Regulatory
Science
LC-MS/MS
Core in
mice
Institutional
Review Board (IRB)
Development
of unbiased
markers in
humans
CTRC Advisory Council
Office of Research Services (ORS)
Sample
Analysis
Food and Drug Administration (FDA)
External Scientific Adviser and Industry

24. Coaching/Writing

25. Passion

26. Persistence

27. Foundations of good research
Good idea
Important topic $$
Capable Coordinators
Recruitment

28. Why do we need clinical research?
New
Drugs
Devices
Procedures
Old
Drugs with new uses …

29. Why
No matter how well you alter (or correct) the pathophysiology in an animal disease model, you wont know whether it will help people until you do it in people
Without clinical and translational research our observations in the basic sciences, in observational cohort studies, and in our clinical practice(s) will simply consume our time but serve no ultimate benefit

30. Recap WHAT IF MY HOW LONG IS THIS STUDY IS GOING TO TAKE? NEGATIVE?
WE’VE GOT
THIS IDEA…
ETHICS
REGULATORY
TRAINING
IS IT WORTH IT?
FINDING
SUBJECTS
FUNDING
STORING THE
INFORMATION
PUBLISHING
STATISTICS
PRESENTING
LIFESTYLE
WHO IS GOING TO DO THE WORK?????

31. Where to find help www.itmat.upenn.edu

32. Overview of Clinical & Translational Research @ Penn
September
8:00-8:30