The goal of this workshop is to create a new collaboration between well-trained patient research advocates and the entities who drive clinical trial standards in the United States including the FDA, pharmaceutical companies, and other similar entities. Patient advocates that have successfully completed the day-long intensive workshop and case-based training in coordination with approximately two dozen FDA oncologists will have a basic knowledge of:

• Oncology drug regulation (overview of U.S. drug laws, the role of the FDA, drug shortages, direct-to-consumer advertising, and globalization of drug development).
• The Investigational New Drug (IND) process (what an IND is, when an IND is required, and what criteria are used by the FDA to decide if a research study may proceed).
• Expanded access programs (single patient INDs, emergency INDs, expanded access protocols).
• Disease-specific considerations (e.g., novel endpoints in specific diseases, biomarker development).
• Expedited development programs (e.g., breakthrough therapy designation, fast track designation).
• Clinical trial design (eligibility criteria, endpoint selection, designing appropriate comparator arms, and use of large expansion cohorts in first-in-human trials).
• Common errors in oncology drug development.
• Matching the right drug to the right patient through biomarker and companion diagnostic development.
• Recruitment of diverse and/or underserved patient populations