Updated FDA Guidance Recommends Inclusion of Patients with Incurable Cancers in Clinical Trials

The Food and Drug Administration (FDA) has issued draft guidance instructing clinical trial sponsors to include patients with incurable cancers in their studies. Many patients with incurable cancers are often excluded from oncology trials.

Richard Pazdur, director of FDA’s Oncology Center of Excellence, remarks, “The FDA believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials. If there is no scientific rationale for excluding these patients, then clinical trial eligibility criteria should be broadened to include these patients, with appropriate informed consent.” Read more here.

(Source: Michael Mezher, Regulatory Affairs Professionals Society, 6/24/21)