US FDA Focuses On Labs, Concomitant Medication To Avert Needless Clinical Trial Exclusions

 
• By Sarah Karlin-Smith

The FDA is pushing sponsors away from template exclusion criteria to highly tailored drug- and trial-specific eligibility requirements in order to widen the patient pool eligible for studies.

dozens of portraits of people to emphasize diversity
New FDA guidance aims to boost trial diversity with more inclusive trial eligibility criteria. • Source: Shutterstock

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