RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says

 
• By Sue Sutter

Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.

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Observational and other types of non-interventional studies are the focus of FDA's latest real-world evidence guidance. • Source: Shutterstock

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