The U.S. Food and Drug Administration (FDA) has issued a draft guidance on “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings” encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials, regardless of whether they have received existing alternative treatment options.
“Historically, many clinical trials have required that participating patients previously received multiple therapies,” noted 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. However, he said the agency now “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.”
This draft guidance is part of the FDA’s broader initiative to encourage rational expanded patient eligibility for oncology clinical trials, Pazdur added.
When finalized, the guidance will provide recommendations to sponsors designing clinical trials of drug and biological products to expand eligibility to patients with incurable cancers, including patients who have not received available therapy/therapies. Such patients may be evaluated in separate cohorts from patients who have received available therapies, the agency indicated.
Edited by Gary Cramer