Track 1: Oncology Product Research and Review for M.D. Oncology Fellows
This fellowship will train physicians currently participating in the NIH Hematology Oncology Fellowship 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.
*Selection of fellows will be dependent upon the availability of funds.
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 residents, who have resided in the US for a total of three of the past five years
- Must be a NIH Hematology Oncology Fellow
NOTE: In order to be approved for logistical and physical access to NIH facilities and systems, candidates must be able to pass a Federal background check using Standard Form-85 (read-SF-85). Section 14 of the Form asks, "in the last year, have you used, possessed, supplied, or manufactured illegal drugs?" The questions pertain to the illegal use of drugs or controlled substances in accordance with Federal laws, even though permissible under state laws. Federal laws supersede all state laws.
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 for the NIH Hematology Oncology Fellowship are reviewed and processed through ERAS. The program is listed as the NIH Clinical Center Program (ACGME ID#1552314155) under the heading for Hematology/Oncology (Internal Medicine). The application deadline is September 1st annually.
For more information about the Oncology Fellowship, please contact Marijo Bilusic, M.D., Ph.D.
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
OMB No.: 0925-0761
Expiration Date: 07/31/2022
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