“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.” “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should be eligible to participate in oncology clinical trials,” Pazdur said in a statement released alongside the draft guidance. (RELATED: FDA calls for inclusion of patients with incurable cancers in oncology trials, Regulatory Focus 24 June 2021)

The recommendation by FDA emphasizes that sponsors still need to follow regulations around informed consent before enrolling patients with incurable cancer in clinical trials.ĭuring the release of the draft guidance in June 2021, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s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, said the guidance is part of a broader initiative by the agency to encourage enrollment of patients with incurable cancers in clinical trials. In their guidance, the agency recommended sponsors include patients with incurable cancer-defined as unresectable, locally advanced, or metastatic disease in solid tumors and/or hematologic malignancies with unfavorable long-term overall survival-in oncology clinical trials even if they met criteria that would otherwise exclude them, such as in situations where a patient had previously received an available therapy in a non-curative setting. The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational therapies.

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