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Comment & Response
May 21, 2019

Need for Randomized Trials to Support Procedural Interventions—Reply

Author Affiliations
  • 1University of Toronto, Toronto, Ontario, Canada
  • 2Mount Sinai Hospital, Toronto, Ontario, Canada
JAMA. 2019;321(19):1939. doi:10.1001/jama.2019.2084

In Reply As Ms Sharma and colleagues highlight, RCTs have gained a dominant role in medical research due to their ability to generate an unbiased estimate of treatment effect in the study sample. However, as discussed in our Viewpoint1 and elsewhere,2 there are significant barriers to the conduct of RCTs for devices and procedures. To rely on intrinsic motivation among physicians to conduct these trials as Sharma and colleagues suggest seems unrealistic, albeit optimistic, given the self-interest of those who develop and promote new health technologies. We believe that in the absence of a regulatory environment that mandates RCTs for procedures, these trials will continue to be relatively uncommon. Important evidence in support of this prediction lies in the 21st Century Cures Act that has enabled the US Food and Drug Administration to promulgate the use of so-called real-world data (eg, observational data from insurance databases, disease registries) in the approval of new indications for pharmaceutical agents.3,4