FDA’s Project Pragmatica and the Rise of Embedded Pragmatic Trials
The traditional randomized controlled trial (RCT) has long been the gold standard for evaluating the efficacy and safety of medical interventions. However, its inherent rigidity, limited generalizability, and operational burden have raised questions about its efficiency in today’s rapidly evolving healthcare landscape. In response, the U.S. Food and Drug Administration (FDA) launched FDA’s Project Pragmatica, […]
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