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Regulators Support ‘Pragmatism’ in Clinical Trials

A panel of experts from inside several major pharma companies discussed regulatory initiatives around pragmatic trials in depth at the recent Summit for Clinical Trial Ops Executives (SCOPE). “I got a fever and the only prescription is more pragmatic trials,” quipped Henry Wei, M.D., head of development innovation at Regeneron and a major fan of TransCelerate’s recent “tabletop exercise” with the U.S. Food and Drug Administration (FDA) as well as the agency’s CDER Center for Clinical Trial Innovation (C3TI) demonstration project focused on the topic. 

Read the full article from Clinical Research News here.

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