The Food and Drug Administration has finalized three guidance documents telling cancer trial sponsors to stop carrying over eligibility restrictions that were never scientifically justified for the specific study being run.
The three documents, posted together on July 27, cover laboratory value thresholds, performance status, and washout periods with concomitant medication rules. Each finalizes a draft first issued in April 2024. Together they represent the agency's clearest statement yet that the standard exclusion criteria copied from one oncology protocol into the next are themselves a problem worth regulating.
