NINDS-FDA/Neurology Clinical Trials Methodology and Regulatory Science

Program Duration: 2 years

The NINDS intramural Clinical Trials Unit within the Office of the Clinical Trials Unit, together with the Division of Neurology (DN) 1, 2, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), are offering an NINDS-FDA/Neurology-Clinical Trial Methodology and Regulatory Science Fellowship.  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 DN, 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, clinical trials operations, regulatory science and biostatistics. This fellowship is suitable for neurologists or neurosurgeons with a strong interest in clinical research and is particularly suited to those who already have some research experience.

Fellowship email:

Faculty and GME Page:
Lauren Reoma, M.D., FAAN, CTU Director and Deputy Clinical Director, NINDS Office of the Clinical Director, lauren.reoma@nih.govPubMed