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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.

*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

Eligibility Requirements

  • 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.

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

First Year

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, 2020 for an earliest start date of July 1, 2020.

Please submit:

  • 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:

Chanelle Case Borden, Ph.D.
IOTF Program Manager
9609 Medical Center Dr.
Rm. 2W234, MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5956
Email: casec@mail.nih.gov

Mentors

While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.

Review list of mentors and projects here.

Burden Statement

OMB No.: 0925-0761
Expiration Date: 07/31/2022

Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing he collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0761). Do not return the completed form to this address.

  • Updated:

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