FDA Tells Cancer Trial Sponsors to Stop Copying Eligibility Rules That Lack Scientific Support

Eligibility criteria exist to select the intended patient population and reduce risk to participants. The performance status guidance addresses the functional scoring systems that determine whether a patient is considered well enough to enroll. MedicalDaily will monitor whether additional guidances in this series are finalized and whether trial sponsors publicly revise protocols in response. Three final guidance documents on cancer trial eligibility criteria, covering laboratory values, performance status, and washout periods with concomitant medications. They are posted on the FDA guidance documents website and announced through the Federal Register under dockets FDA-2024-D-1402, FDA-2024-D-1377 and FDA-2024-D-1376.