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Real-World Evidence Study Registration May Help Drive FDA Acceptance

 
• By Cathy Kelly

US FDA’s David Martin encourages sponsors to register observational studies on drug effectiveness to enhance transparency and agency confidence in the data.

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Registering RWE Studies Feasible, FDA's Martin Says

Sponsor registration of retrospective observational research could help FDA determine whether a study has validity and can be used to support effectiveness decisions, David Martin, associate director for real world evidence analytics in the agency’s Office of Medical Policy, suggested at the recent International Society for Pharmacoeconomics and Outcomes Research Summit 2019.

Study sponsors are not required to register studies using real world evidence (RWE) on sites such as ClinicalTrials.gov. And Martin cautioned he couldn’t offer an official FDA position on the...

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