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US FDA's Califf On Real-World Evidence: 'Use It For The Right Purposes'

This article was originally published in SRA

Executive Summary

Randomized clinical trials have long been extolled as the gold standard for establishing drug efficacy and safety. However, US Food and Drug Administration Commissioner Robert Califf has his sights set on increased use of another type of research for informing regulatory decision-making: randomized clinical practice studies.

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