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Regulatory Focus™ > News Articles > 2019 > 6 > FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

Posted 07 June 2019 | By Ana Mulero 

FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

The US Food and Drug Administration (FDA) said Friday it will host a 2-day public workshop on leveraging randomized clinical trials to generate real-world evidence (RWE) for regulatory decisions.

The Duke-Margolis Health Policy Center will convene the workshop under a cooperative agreement with FDA to explore how randomized clinical trial designs, including those that incorporate pragmatic design elements, can use real-world data (RWD) to generate RWE in clinical settings. Considerations noted in the discussions will inform the potential usefulness of RWE to support regulatory decision-making.

Set topics relate to the “selection of interventions appropriate in clinical care settings, study design elements and study populations, capturing outcomes in clinical care settings and addressing potential challenges around blinding, randomization and bias,” FDA said via a Federal Register notice. Those specific to regulatory considerations include safety and product monitoring as well as data integrity.

The workshop is part of FDA’s ongoing effort to implement the RWE framework that the Center for Drug Evaluation and Research (CDER) unveiled last December. FDA says it intends to issue guidance on integrating clinical trials into clinical care settings as part of that framework. CDER reviewed the framework in a March webinar, following industry comments that lauded its release with some caveats.

Under the RWE framework, the agency released draft guidance last month on submissions using RWD and RWD for drugs and biologics. Upcoming guidance topics under the new RWE framework include use of mobile technology and registries, according to FDA Oncology Center of Excellence acting associate director Sean Khozin. FDA expanded an RWE demonstration project on Phase IV trials in April.


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