MGH Division of Clinical Research

Design and Conduct of Clinical Trials1

Course directors: Gregory Robbins, MD, MPH George Papakostas, MD

Design and Conduct of Clinical Trials is an intensive fourteen-session course offered from early-September through late October. Physicians with a serious interest in clinical trials will be introduced to theoretical and practical issues facing clinical researchers. Course participants will learn how to envision, plan, develop and execute effective clinical trials. Study content includes research designs, protocols, ethical patient recruitment, informed consent, regulations, and clinical trial management.

The course is ideally suited for clinical fellows starting their research years, junior faculty pursuing careers in clinical research and physicians with an interest in becoming more actively involved in clinical research.

All participants are expected to use the course curriculum to develop and present a trial design at the final session of the course.

Enrollment is limited to facilitate interaction and individual attention. To ensure placement in the course, early application is recommended. All applications will be reviewed in mid-August.

Please contact dcredu@partners.org with any questions.


Program: Clinical Research Investigator

Sponsor: MGH Division of Clinical Research

Modules

Session 10: Working Session with Course Faculty
Session 11: International Trials | Getting into the Game
Session 12: Negotiating with Industry: What They Want, What You Need
Session 13: Biomarkers | Medical Devices
Session 14: Participant Presentations
Session 15: Participant Presentations
Session1: Introduction to Clinical Trials
Session 2: Design and Analysis of Randomized Trials
Session 3: Working with a Statistician
Session 4: Selecting and Recruiting | Ethical Issues in Clinical Research
Session 5: Phase I and Phase II Trials
Session 6: Complying with Requirements | Phase IV Trials
Session 7: Data Management | Clinical Trial Funding Strategies
Session 8: Protecting Patients - How and Why?
Session 9: Phase III Trials | Alternative Study Designs

Past Offerings

Design and Conduct of Clinical Trials1 Sept. 1, 2016