Joint Fellowship Training Program
Clinical Oncology Product Research/Review for 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 the clinical research and development process to facilitate the movement of drugs, biologics, and devices from the basic bench science to commercialization. Those eligible to participate will possess a M.D. or M.D./Ph.D. degree in a relevant field of clinical training and hold US citizenship or US permanent residency. Participants in this program will spend the first year at NCI and train in the participating oncology-training programs followed by two years training in product research/review at FDA and NCI. While at FDA, fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles and practices of FDA medical product review, including issues related to clinical trial design, clinical pharmacology, monitoring of clinical trials, identification of biomarkers, and pharmacoepidemiology. Fellows will also have the opportunity to participate in medical product development research projects at both agencies. While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff. The program timeframe will be for up to three years and include up to two fellows per year.