FDA Encourages Inclusion of Patients with Incurable Cancers in Clinical Trials

On June 24, 2021, the U.S. Food and Drug Administration (FDA) issued drafted guidance that encourages the inclusion the patients with incurable cancers in clinical trials, regardless of their treatment history. When finalized, the FDA's guidance will "provide recommendations to sponsors designing clinical trials of drug and biological products to expand eligibility to patients with incurable cancers."

It will also provide guidance on how to address patients who have not received prior therapies, such as using separate cohorts.

Read the full FDA draft guidance for sponsors.

Posted 6/25/2021