Improving cancer drug research: FDA reworks and finalizes guidance documents
To align with President Biden’s renewed push around his Cancer Moonshot project, the FDA on Tuesday released new guidance to companies sponsoring oncology trials and focused on two important concepts — master protocols (a long-time Janet Woodcock favorite) and expansion cohorts — while FDA also emphasized how trials should include participants over 75 years old.
The 24-page final guidance on master protocols, building on a draft from October 2018, explains how to run these trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same trial structure.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.