Graduation Medical Education (GME): Clinical Trial Methodology and Regulatory Science

Fellowship Program Directors:
Robin Conwit MD, NINDS
Heather Fitter, MD, FDA
Dietrich Haubenberger, MD, NINDS
John Marler, MD, FDA

Overview
The NIH National Institute of Neurological Disorders and Stroke (NINDS) and the FDA Division of Neurology Products (DNP) are pleased to announce a fellowship opportunity offering training in clinical trial methodology and regulatory science. This joint NIH-FDA fellowship offers a unique opportunity to develop fundamental clinical research skills and understanding of the pathways regulatory. The rapid pace of discovery in the basic neurosciences has created opportunities to translate research advances into improved therapeutics for people living with neurological disorders. Accelerating this process will require investigators with comprehensive expertise in all facets of clinical research. Advanced knowledge of both clinical trial methodology and the regulatory pathways leading to approval of new therapeutics is essential for successful human research. While many neurologists and neurosurgeons working in academia or government settings receive formal training in clinical research methodology, most receive little formal training in the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of drugs and medical devices.

Program Structure
The two-year NIH-FDA fellowship will include hands-on participation both in neurology clinical research conducted at the NIH Clinical Center in Bethesda, Maryland, and in neurology clinical research regulatory review at the FDA Federal Research Center in Silver Spring, Maryland. Fellows will participate in activities related to the planning, implementation, conduct, data and safety monitoring, and regulation of trials either conducted or funded by the NINDS and regulated by the FDA. During the two-year fellowship period, the emphases will be:

  • Acquiring the basic skills necessary for the conduct of clinical research with most activities in the first year taking place at the NINDS Intramural Research Program and the NINDS Office of Clinical Research.
  • Intensive participation in the full spectrum of activities at FDA within DNP, beginning in the first year and increasing in the second year, ranging from pre-investigational discussions with clinical investigators about first-in-human drug trials to analysis of multi-center trials leading to possible approval of new medical products.
  • In addition, a research project oriented towards clinical trial methodology and regulatory science will be completed during the fellowship.

Application Information
NIH Graduate Medical Education Application
Applications are accepted during the course of the year. Selected candidates will be invited for an on-site interview. Fellowships are available on an annual basis. We seek applicants planning careers in the clinical neurosciences (Neurology or Neurosurgery) and therapeutics development in academic medicine, government service, or other settings. Graduates of accredited residency programs or clinical fellows in Neurology or Neurosurgery in academia or at the NIH within 10 years of training completion are encouraged to apply. Priority will be given to applicants who have identified an area of clinical interest in a given subspecialty or disease area and who have developed plans or pilot studies for potential clinical research projects.

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This page last updated on 10/13/2017

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