Track 1: Oncology Product Research and Review for M.D. Oncology Fellows
This fellowship will train physicians in aspects of clinical trials methodology and analysis, epidemiology, clinical aspects of medical product development, and regulation, as it relates to clinical research to facilitate the movement of drugs, biologics, and devices from the basic bench science to commercialization.
Training Goals and Outcomes
- Clinical training in an oncology subspecialty to meet the requirements for board eligibility in that subspecialty
- Understanding of the various legal and regulatory aspects of cancer product development
- Understanding the review process for regulatory pathways
- Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research subjects and conflict of interest
- Training and experience in clinical trial design, clinical pharmacology, pharmacoepidemiology, and the product development process in the context of clinical research
- Board-certified or board-eligible in internal medicine, pediatrics, surgery, and/or radiation oncology
- U.S. citizenship or permanent residency
Curricula and Responsibilities
Fellows will train in the participating oncology training programs of the NCI. During this year, fellows will undertake the primary care of both inpatients and outpatients entered into clinical trials and develop expertise in cancer treatment as well as the specifics of clinical trial design.
Second and Third Year
During the second and third years, course work and practical experience will be provided at both agencies in a wide variety of topics such as clinical trial design, clinical pharmacology, pharmacoepidemiology, and the legal and regulatory aspects of new product development. At both NCI and FDA, fellows will have the opportunity to become involved in medical product development research projects, including such topics as clinical trial design and analysis, drug regulation and post-marketing surveillance, and the basic science, epidemiology, and clinical aspects of the new agents. There will also be the opportunity to spend approximately one day per week in continued clinical activities at NCI.
How to Apply
Applications are due January 31, 2017 for an earliest start date of July 1, 2017.
- Curriculum Vitae
- Personal statement of research goals
- Three letters of reference
For more detailed information and application guidelines view the NCI-FDA Research and Regulatory Review Fellowships Guidelines for Application (PDF)
Send application materials to:
Jonathan S. Wiest, Ph.D.
Director, Center for Cancer Training, NCI
9609 Medical Center Dr.
Rm. 2W104, MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5628
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.