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Clinical Trial Methodology

Program Duration: 1–2 years



The Division of Neurology Products (DNP), U.S. Food and Drug Administration (FDA), and the Office of Clinical Research (OCR) are offering a Clinical Trial Methodology and Regulatory Science Fellowship. Expanding the opportunities to large, multi-center trials, the fellows will participate in activities related to the planning and regulation of multi-center trials funded by the NINDS extramural program and regulated by the FDA. Working with the directors of the DNP and OCR, the Fellow will receive training in all aspects of clinical trials including concept evaluation, protocol development, statistical design, trial implementation, safety monitoring, ethical considerations, and regulatory sciences. During the first year, the emphasis will be on acquiring the basic skills necessary for the conduct of clinical research with most activities taking place at NIH along with early exposure to the FDA environment. During the second year, increasing independence in clinical research will be accompanied by more intensive participation in the full spectrum of activities in DNP, ranging from pre-investigational discussions with clinical investigators about first-in-human drug trials to analysis of complicated multi-center trials leading to possible approval of new medical products. In addition, Fellows will engage in implementing a clinical research project at the NIH Clinical Center and participate in a weekly subspecialty clinic of their choice. The program is customized but generally will include coursework on clinical research methodology and statistics. This fellowship is suitable for physicians or neuroscientists with a strong interest in clinical research and is particularly suited to those who already have some research experience.

Faculty

Dietrich Haubenberger, Director, Clinical Trials Unit, haubenbergerd@ninds.nih.gov

Avi Nath, M.D., Clinical Director, NINDS, ClinicalDirector@ninds.nih.gov

Billy Dunn, M.D., Medical Officer, Division of Neurology Products, FDA, bill.dunn@fda.hhs.gov