Design & Conduct of Clinical Trials

Design and Conduct of Clinical Trials
Sponsored by the Division of Clinical Research

The purpose of this online course in clinical trial design is to introduce the theory and practice of clinical trials. The design and conduct of clinical research will be reviewed in detail in order to enable course participants to plan, propose, and develop effective clinical trials. Essentials of clinical trials including specific trial designs (Phase I-IV), patient recruitment and selection, patient informed consent, designing and writing study protocols, managing the ongoing operations of a clinical trial, and trial regulatory issues will be reviewed and analyzed. You will be responsible for attending course sessions and will actively engage in case analyses, written work, discussions, and in topical break-out sessions. During the course, you will be required to design, develop and present a clinical trial of your own choosing.

Upon completion of the course, you will be able to:

1. Critically evaluate the design and conduct of clinical trials.
2. Understand the range of controversial issues relevant to clinical research.
3. Write an Informed Consent document.
4. Produce and present a clinical trial proposal.

Speaker: Gregory Robbins, MD, Associate Professor of Medicine, Dept of Medicine, Infectious Disease Division, MGH