Improving the validity of noninterventional comparative effectiveness research by basing study design on a specified existing randomized controlled trial

• Wing, Kevin ^[1] ; Leyrat, Clémence ^[2]
  1. [1] University of Glasgow

     University of Glasgow

     Reino Unido

     
  2. [2] London School of Hygiene & Tropical Medicine

     London School of Hygiene & Tropical Medicine

     Reino Unido

     
• Localización: American journal of epidemiology, ISSN-e 1476-6256, ISSN 0002-9262, Vol. 194, Nº. 4, 2025, págs. 913-917
• Idioma: inglés
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• Resumen

  • 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.