23 February 2019 - Cancer therapies are typically evaluated based on their ability to control the growth of a tumor or extend life. 

Tumour response and survival data are strong trial endpoints that remain the mainstay of regulatory review, but cancer patients have other meaningful concerns as well, such as coping with treatment-related side effects that can impact their ability to function, as well as other aspects of their quality of life. In short, cancer therapies treat patients … not just their disease.

The Oncology Center of Excellence Patient-Focused Drug Development Program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations.

Read FDA blog