The Drug Development Paradigm in Oncology

Description

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 effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"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.

Marketing Information

https://www.nap.edu/24742

Thank you for proceeding with this offer.

National Academies Press has chosen to review this offer before it proceeds.

You will receive an email update that will bring you back to complete the process.

You can also check the status in the My Offers area
Loading...

Please wait while the payment is being prepared.
Do not close this window.

Bibliographic Information
  • Pub date: March 2018
  • English
  • 9780309457941 / 0309457947
  • United States
  • Paperback
  • Primary Price: 42 USD
  • Pages: 124
  • National Academies Press
  • Readership: Professional and scholarly
  • Publish State: Published
  • Copyright Year: 2017
  • Copyright Information: Copyright year 2017
  • Dimensions: 9 X 6 inches
  • Reference Code: 10.17226/24742