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Books > Medicine > Clinical & internal medicine > Diseases & disorders > Oncology
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The Drug Development Paradigm in Oncology - Proceedings of a Workshop (Paperback)
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The Drug Development Paradigm in Oncology - Proceedings of a Workshop (Paperback)
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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. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda
General
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