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Pharmaceuticals / Regulatory Affairs

Drugmakers Seek Clarity on FDA’s Plan for Real-World Evidence in Trials

Feb. 21, 2019

Drug sponsors are eager for the FDA to embrace real-world evidence, but several companies are asking the agency to clarify how it can be used in clinical trials.

The agency issued a framework for a real-world evidence program late last year and called for stakeholder comments. Some of the world’s largest drugmakers accepted that invitation in comments submitted to the agency this month.

Several comments latched on to the agency’s suggestion that it might be open to using data from observational studies that “replicate” randomized trial results and worried that the word is too vague.

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