FDA’s COVID-19 Pandemic Plan Calls For Ongoing Clinical Trial Innovation

 
• By Brenda Sandburg

Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.

Pandemic plan
FDA COVID-19 Pandemic Recovery and Preparedness Plan recommends clinical trial innovations • Source: Shutterstock

A continued focus on innovation in clinical trials is among the steps the US Food and Drug Administration could take to improve its response to the COVID-19 pandemic and future public health emergencies, a report commissioned by the agency concludes.

The recommendations are included in FDA’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) summary report, which notes that trial sponsors are eager to understand how FDA will guide clinical trial conduct through the remainder of the pandemic and beyond

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