Schedule of Didactic Sessions | Session 16
Session 16
Date: Thurs. 5/21/09
Topics and Speakers:
Clinical Trials: Richard Eastman, MD
Drug Development: Daria Mochly-Rosen, PhD
Topic 1: Clinical Trials
Learning Objectives: After attending this session, the learner should be able to:
- explain how the rights of human volunteers are safeguarded in clinical trials.
- discuss features of the design of clinical trials that minimize the potential for bias influencing the results.
- identify potential outcomes for diabetes-related clinical trials.
Key words: clinical trial design, outcomes, diabetes clinical trials
Supplementary Resources :
- The Diabetes Control and Complications Trial Research Group. Lifetime Benefits and Costs of Intensive Therapy as Practiced in the Diabetes Control and Complications Trial. JAMA 1996;276:1409-1415. On reserve.
- Clinical Trials. Design, Conduct, and Analysis. Curtis L. Meinert (ed). Oxford University Press. New York . 1986. In Lane Library.
- Division of Pediatric Endocrinology and Diabetes, Stanford University (http://dped.stanford.edu/)
Topic 2: Drug Development
Learning Objectives: a case study of bench to bedside experience.
Keywords: Basic Research, Clinical Application, Reperfusion Injury, Mitochondrial Infarction.
Required Reading: none
Recommended Reading:
- Roe, MT et al. Intracoronary KAI-9803 as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction. Circulation (2007).
- et al. Impaired perfusion after myocardial infarction is due to reperfusion-induced deltaPKC-mediated myocardial damage. Cardiovascular Research (2007).
- Inagaki, K et al. Inhibition of delta-Protein Kinase C Protects Against Reperfusin Injury of the Ischemic Heart In Vivo. Circulation (2003).
- Chen, L et al. Opposing cardioprotective actions and parallel hypertrophic effects of deltaPKC and epsilonPKC. PNAS (2001)