Track 1: Oncology Product Research and Review for M.D. Oncology Fellows

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

• Must be a NIH Hematology Oncology Fellow
• 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
• Must pass the FDA Ethics for Non-Employees Scientists review

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 for the IOTF program typically open in May; however, there is some flexibility with your desired start date. Please discuss your career goals with the program coordinator to determine your ideal timeline. Submit your application at Train at NCI by the application deadline. As part of the application, you will be asked to submit:

• Curriculum Vitae
• Personal statement of research goals
• Three letters of reference

For more detailed information and application guidelines, visit Train at NCI.

To become an NIH Hematology Oncology Fellow, visit the NIH Hematology Oncology Fellowship website.

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.