Abstract

This issue of the American Journal of Epidemiology includes 3 articles (2 reporting original analyses and 1 systematic review) in which noninterventional studies used an existing randomized controlled trial (RCT) as a reference standard to inform noninterventional study design and against which to benchmark results. This commentary provides a brief background on the challenges of noninterventional comparative effectiveness research, before elaborating on (1) the potential benefits and challenges of basing noninterventional study design on a specified existing RCT and (2) the distinction between designing analysis based upon a specified existing RCT and studies based solely upon a hypothetical target trial. Finally, several recommendations for the conduct and reporting of noninterventional studies based on existing RCTs are provided.

This article is part of a Special Collection on Pharmacoepidemiology.

This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://dbpia.nl.go.kr/journals/pages/open_access/funder_policies/chorus/standard_publication_model)
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