FDA Recommends Expanding Clinical Trial Eligibility for Patients with Incurable Cancers

The U.S. Food and Drug Administration (FDA) has issued draft guidance for expanding investigational clinical trial options for patients with incurable cancers, encouraging sponsors to waive rules requiring patients to have undergone multiple existing alternative therapies to enroll.

“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,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “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,” he said.

When finalized, the document, “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings,” will provide recommendations for expanding eligibility for patients with incurable cancers, including evaluating patients who have not received available therapies in separate cohorts from those who have.

Source: FDA press release, June 24, 2021.