An ad hoc committee will plan and host a 1.5-day public workshop to examine the drug development paradigm for cancer therapy. The workshop will feature invited presentations and panel discussion on topics that may include
- Challenges with the traditional phased drug development paradigm in the age of targeted therapies and opportunities for using new approaches to cancer therapy development and regulatory review.
- Best practices for cancer drug development and review (e.g., trial design, statistical approaches, ethical considerations and informed consent, industry–Food and Drug Administration interactions).
- Lessons learned from recent expedited drug approval processes.
- Evidence requirements for cancer therapies before and after regulatory approval, and the mechanisms needed to generate this knowledge (e.g., clinical trials, “real-world” experiential data, combination approaches).
- Examples of international regulatory approaches.
The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. A summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
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