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

Guowei Li; Tolulope T Sajobi; Bijoy K Menon; Lawrence Korngut; Mark Lowerison; Matthew James; Stephen B Wilton; Tyler Williamson; Stephanie Gill; Lauren L Drogos; Eric E Smith; Sunita Vohra; Michael D Hill; Lehana Thabane; 2016 Symposium on Registry-Based Randomized Controlled Trials in Calgary

doi:10.1016/j.jclinepi.2016.08.003

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.

Authors

Affiliations

¹ Department of Clinical Epidemiology & Biostatistics, McMaster University, 1280 Main St W, Hamilton, Ontario L8S 4L8, Canada; St. Joseph's Healthcare Hamilton, McMaster University, 50 Charlton Ave E, Hamilton, Ontario L8N 1Y2, Canada.
² Department of Community Health Sciences, O'Brien Institute for Public Health, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada; Department of Clinical Neurosciences, University of Calgary, 500 University Dr NW, Calgary, Alberta T2N 1N4, Canada; University of Calgary Hotchkiss Brain Institute, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
³ Department of Clinical Neurosciences, University of Calgary, 500 University Dr NW, Calgary, Alberta T2N 1N4, Canada; University of Calgary Hotchkiss Brain Institute, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
⁴ Department of Community Health Sciences, O'Brien Institute for Public Health, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
⁵ Department of Community Health Sciences, O'Brien Institute for Public Health, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada; Department of Medicine, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
⁶ Libin Cardiovascular Institute of Alberta, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
⁷ Department of Pediatrics, University of Alberta, 116 St & 85 Ave, Edmonton, Alberta T6G 2R3, Canada.
⁸ Department of Clinical Epidemiology & Biostatistics, McMaster University, 1280 Main St W, Hamilton, Ontario L8S 4L8, Canada; St. Joseph's Healthcare Hamilton, McMaster University, 50 Charlton Ave E, Hamilton, Ontario L8N 1Y2, Canada. Electronic address: [email protected].

PMID: 27555082
DOI: 10.1016/j.jclinepi.2016.08.003

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*