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The Drug Development Paradigm in Oncology: Proceedings of a Workshop (2018)

Chapter: Appendix A: Statement of Task

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Suggested Citation:"Appendix A: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Appendix A

Statement of Task

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.

Suggested Citation:"Appendix A: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Suggested Citation:"Appendix A: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Page 115
Suggested Citation:"Appendix A: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body’s immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of efforts—by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)—to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities.

To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

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