title: Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research?
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.
authors.affiliation: 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.
authors.forename: Guowei
authors.initials: G
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Tolulope T
authors.initials: TT
authors.lastname: Sajobi
authors.affiliation: 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.
authors.forename: Bijoy K
authors.initials: BK
authors.lastname: Menon
authors.affiliation: 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.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Korngut
authors.affiliation: Department of Community Health Sciences, O'Brien Institute for Public Health, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
authors.forename: Mark
authors.initials: M
authors.lastname: Lowerison
authors.affiliation: 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.
authors.forename: Matthew
authors.initials: M
authors.lastname: James
authors.affiliation: Libin Cardiovascular Institute of Alberta, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Wilton
authors.affiliation: Department of Community Health Sciences, O'Brien Institute for Public Health, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
authors.forename: Tyler
authors.initials: T
authors.lastname: Williamson
authors.affiliation: 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.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Gill
authors.affiliation: Libin Cardiovascular Institute of Alberta, University of Calgary, 2500 University Dr NW, Calgary, Alberta T2N 1N4, Canada.
authors.forename: Lauren L
authors.initials: LL
authors.lastname: Drogos
authors.affiliation: 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.
authors.forename: Eric E
authors.initials: EE
authors.lastname: Smith
authors.affiliation: Department of Pediatrics, University of Alberta, 116 St & 85 Ave, Edmonton, Alberta T6G 2R3, Canada.
authors.forename: Sunita
authors.initials: S
authors.lastname: Vohra
authors.affiliation: 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.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.affiliation: 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: thabanl@mcmaster.ca.
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends*; D015340:Epidemiologic Research Design; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012042:Registries / Q000706:statistics & numerical data*
keywords: Clinical trial; Effectiveness; Pragmatic trial; Real-world setting; Registry; Registry-based randomized controlled trial