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Joint Fellowship Training Program
Program 4
Cancer Prevention 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).
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