Getting real at the FDA - The changing tide on real-world evidence in drug development

Wednesday, May 26, 2021 2pm ET / 11am PT

FDA is opening up to data gathered outside the hermetically sealed clinical trial setting as regulators recognize the need for a more flexible framework for evaluating treatments, helped along by the 21st Century Cures Act. This move is coinciding with growing expertise among technology providers to tap real-world data sources and analyze them.

Meanwhile, real-world evidence teams are cropping up across biopharma as the industry invests in talent and infrastructure to deploy this sort of data in their R&D efforts. They’re using RWE to identify biomarkers that can be used to select clinical trial patients and tapping patient records to help design and optimize trial protocols, plus help identify optimal trial sites.

Real-world evidence could also serve as a control arm in certain studies—for instance, rare cancers—to reduce trial duration, allow for a smaller number of participants and save money. And, of course, real-world evidence is a natural for post-marketing studies looking to divine long-term patient outcomes and safety.

Regulatory challenges remain, and as a new approach that requires significant investment, real-world evidence use requires the right talent and technology. Where to find that talent and technology, and how to deploy it internally or with partners, are some of the questions companies face. We’ll address these questions and more with the help of current practitioners in the field.

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