BioCentury
ARTICLE | Politics & Policy

FDA calls for cancer outcomes partnership, vows transparency on surrogates

June 25, 2018 7:36 PM UTC

FDA Commissioner Scott Gottlieb Monday called for the private sector to partner with government to provide real-world data about cancer therapy outcomes. He also announced the agency’s intention to post data on surrogate endpoints that have supported approvals.

In remarks to the National Comprehensive Cancer Network policy summit, Gottlieb said that rapid advances in cancer treatment, especially adoption of immunotherapies, has “created a need for reliable databases for optimizing patient outcomes and minimizing safety risks.” The necessary data cannot be created by a single payer, manufacturer or provider, he said...