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STEP Program Examines Clinical Trials

The staff training in extramural programs (STEP) will present "Clinical Trials on Trial: Protecting Human Subjects of Clinical Research," a module in its Current Controversies in Medicine series, on Thursday, May 17, from 8:30 a.m. to 4 p.m. in the Natcher Conference Center's main auditorium.

Recent media reports have raised questions about the safety net for protecting human participants in clinical trials. The challenge is to ensure protection without unnecessarily slowing the pace of research and discovery. The module will provide a forum to discuss current controversies in protecting participants in clinical trials. Issues to be addressed will include adverse event reporting and the roles of principal investigators, institutional review boards, data and safety monitoring boards, and NIH and FDA staff in monitoring patient safety. Examples of acceptable data and safety monitoring plans for phase I, II and III clinical trials will be presented.

The program will begin with plenary talks by Janet Wittes from Statistics Collaborative and Bernard Lo from the University of California, San Francisco. NIH deputy director for extramural research Dr. Wendy Baldwin and David LePay acting director, Office for Human Research Trials, FDA, will address the respective roles of NIH and FDA in data and safety monitoring and adverse event reporting. A panel with Larry Friedman of NHLBI, David Shore of NIMH, Michaele Christian of NCI, and Dennis Dixon of NIAID will discuss how institutes and centers are addressing their responsibilities in these areas.

Discussing the conduct of clinical research in developing countries will be a panel including James Lavery of the Fogarty International Center, Robert Levine of Yale, Christine Grady of the Clinical Center's bioethics department and Don Francis of Vaxgen. They will address ethical and social issues that arise in the design, conduct and followup of such research.

All employees are invited. Report attendance (or viewing of an archived videocast) to your training supervisor for ESA credit. No advance registration is necessary. Inform the STEP office at 435-2769 about any need for sign language interpretation or other reasonable accommodation by May 10.

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