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Track 4: Cancer Prevention Product Research and Review for Postdoctoral Research Fellows

This fellowship, conducted in partnership with the Cancer Prevention Fellowship Program, will provide training in cancer prevention (e.g., chemoprevention, vaccination, and early detection). Individuals will be trained in the drug, biologic, or device development and approval processes and their application to study populations (including healthy subjects) to facilitate the movement of novel approaches from the bench to the community. Combining training in public health, cancer prevention research, and research-related regulatory overview will allow individuals to develop expertise across these disciplines.

*Selection of fellows will be dependent upon the availability of funds.

Training Goals and Outcomes

  • Understanding the design and analysis of clinical trials, familiarity with the IRB approval process, and determining appropriate clinical endpoints in cancer prevention and early detection trials.
  • Participation in multidisciplinary cancer prevention research
  • Understanding the review process for regulatory pathways
  • Understanding and participation in the development of product standards and guidance documents, particularly with respect to regulations for use of agents with limited preclinical data in humans
  • Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research subjects and conflict of interest
  • Understanding and developing guidelines for use of agents in chemoprevention trials that have approved indications only in the treatment setting
  • Understanding and developing criteria for "acceptable drug toxicity" in chemoprevention trials, where study subjects are often healthy volunteers
  • Understanding and developing criteria to determine acceptable surrogate clinical endpoints unique to cancer prevention trials (in contrast to treatment endpoints: e.g., tumor response, survival)

Eligibility Requirements

  • Doctoral degree (M.D., Ph.D., or equivalent)
  • U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years (September 1)
  • Applicants must have less than 5 years relevant postdoctoral training at the time of appointment

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

Individuals will pursue a master's degree in clinical investigation (M.S.) or in public health (M.P.H). Those already possessing a master's degree, will come directly to the NCI/FDA and begin the activities described below.

Second Through Fourth Year

At the NCI fellows will participate in the Cancer Prevention Fellowship Program’s Learning for early Engagement And Development (LEAD) program, weekly Fellows Research Meetings and Colloquia series, Grants and Grantsmanship Workshop, Effective Presentations Workshop, and other professional development activities.

At the FDA, depending upon research interests, fellows will choose from among the product or clinical divisions of the participating FDA Centers. In a particular product division, fellows interested in regulatory research and related regulatory experience will work with a principal investigator or branch chief (or designee) selected through mutual agreement. Fellows may elect to work in a product division or in a pharmacology/toxicology branch in a clinical division. Both clinical and non-clinical fellows will have the option of performing translational research in the participating division, branch, or office.

Fellows will participate in various regulatory activities of the division at the FDA where they undertake their research. Fellows will spend approximately 40% of their time in product, pharmacology/toxicology, or clinical reviews and policy and guidance document development. They will participate in grand rounds and meetings related to regulatory activities. Additionally, fellows will attend courses offered by the participating FDA Centers and pass required testing in reviewer training.

Fellows' performance will be evaluated by Fellowship Program staff at the NCI and FDA, research mentors, and scientific staff overseeing fellows' activities at either institution.

How to Apply

To be considered for this, you must be accepted into the Cancer Prevention Fellowship Program.  Applications open May 1st through mid-August annually.  

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.

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