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FDA Encourages Inclusion of Patients With Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies


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On June 24, 2021, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, made the following statement:

Richard Pazdur, MD

Richard Pazdur, MD

“Today, the FDA issued a draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical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.

“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.

“This draft guidance is part of the FDA’s broader initiative to encourage rational expanded patient eligibility for oncology clinical trials.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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