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 cancer therapies in the drug development pipeline. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit 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—to accelerate the development and evaluation of promising new cancer therapies, especially for cancers that currently lack effective treatments.
To explore this new landscape in cancer drug development, the National Cancer Policy Forum, in collaboration with the Forum on Drug Discovery, Development, and Translation, hosted a 1.5-day public workshop, The Drug Development Paradigm in Oncology, on December 12-13, 2016. The 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 workshop proceedings is a summary of the presentations and discussions at the workshop.