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

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

• Must be an NCI Cancer Prevention Fellow
• 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)
• Must pass the FDA Ethics for Non-Employees Scientists review

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

The NCI Cancer Prevention Fellowship Program application satisfies the application requirement. Please discuss your career goals with the program advisors to determine the best time to apply. Submit an updated CV and personal statement of research goals to the IOTF Program Coordinator by the end of July.

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.