Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research?

J Clin Epidemiol. 2016 Dec;80:16-24. doi: 10.1016/j.jclinepi.2016.08.003. Epub 2016 Aug 20.

Abstract

Registry-based randomized controlled trials are defined as pragmatic trials that use registries as a platform for case records, data collection, randomization, and follow-up. Recently, the application of registry-based randomized controlled trials has attracted increasing attention in health research to address comparative effectiveness research questions in real-world settings, mainly due to their low cost, enhanced generalizability of findings, rapid consecutive enrollment, and the potential completeness of follow-up for the reference population, when compared with conventional randomized effectiveness trials. However several challenges of registry-based randomized controlled trials have to be taken into consideration, including registry data quality, ethical issues, and methodological challenges. In this article, we summarize the advantages, challenges, and areas for future research related to registry-based randomized controlled trials.

Keywords: Clinical trial; Effectiveness; Pragmatic trial; Real-world setting; Registry; Registry-based randomized controlled trial.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Comparative Effectiveness Research / methods*
  • Comparative Effectiveness Research / statistics & numerical data
  • Comparative Effectiveness Research / trends*
  • Epidemiologic Research Design*
  • Humans
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Registries / statistics & numerical data*