Former FDA Commish Califf: Weighing the Benefits & Risks of the Growing Number of Observational Treatment Assessments

July 31, 2020

In a recently published JAMA Viewpoint, former FDA Commissioner Robert Califf and colleagues mused about a growing concern about inferring causation about benefits and risks of potential therapeutics for COVID-19 derived from nonrandomized studies.  The authors mused, ” whether these reports just add noise, confusion, and false confidence.” Does this approach help contribute to the knowledge and the need for well-designed randomized clinical trials and accelerate their delivery?1 Or do observational studies reduce the likelihood of a properly designed trial being performed, thereby delaying the discovery of reliable truth?

The authors warn healthcare providers, patients, and policymakers to stop the rush to judgment in the absence of reliable evidence, the proliferation of observational treatment comparisons will hinder the goal of finding effective treatments for COVID-19—and a great many other diseases.

(Source:  Califf RM, et al., JAMA, July 31, 2020)

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