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

 
• By Sue Sutter

Commissioner champions data from randomized clinical practice studies to support benefit/risk decisions but also sees value in other types of data generated outside the traditional clinical trial setting.

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

Studies in which patients are randomized within a clinical practice setting provide the best opportunity for using "real world evidence" to assess a drug's

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