4.6 Article

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

Journal

JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 80, Issue -, Pages 16-24

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2016.08.003

Keywords

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

Funding

  1. Father Sean O'Sullivan Research Award
  2. CSC
  3. Alberta Innovates Health Solutions
  4. O'Brien Institute for Public Health
  5. Hotchkiss Brain Institute
  6. Alberta Strategy for Patient-Oriented Research
  7. Heart and Stroke Foundation (HSF)/University of Calgary Professorship in Stroke
  8. HSFC/University of Calgary Professorship in Stroke Imaging
  9. Research Institute of St. Joseph's Healthcare Hamilton
  10. Alberta Innovates [201400526, 201300690] Funding Source: researchfish

Ask authors/readers for more resources

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. (C) 2016 Elsevier Inc. All rights reserved.

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