USA – Patients with incurable cancer should be included in trials for new therapies

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.

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 recommendation by FDA emphasizes that sponsors still need to follow regulations around informed consent before enrolling patients with incurable cancer in clinical trials…