Literature DB >> 27555082

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

Guowei Li1, Tolulope T Sajobi2, Bijoy K Menon2, Lawrence Korngut3, Mark Lowerison4, Matthew James5, Stephen B Wilton6, Tyler Williamson4, Stephanie Gill3, Lauren L Drogos6, Eric E Smith3, Sunita Vohra7, Michael D Hill2, Lehana Thabane8.   

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.
Copyright © 2016 Elsevier Inc. All rights reserved.

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

Mesh:

Year:  2016        PMID: 27555082     DOI: 10.1016/j.jclinepi.2016.08.003

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  55 in total

1.  Registry-based trials: a potential model for cost savings?

Authors:  Brett R Anderson; Evelyn G Gotlieb; Kevin Hill; Kimberly E McHugh; Mark A Scheurer; Carlos M Mery; Glenn J Pelletier; Jonathan R Kaltman; Owen J White; Felicia L Trachtenberg; Danielle Hollenbeck-Pringle; Brian W McCrindle; Donna M Sylvester; Aaron W Eckhauser; Sara K Pasquali; Jeffery B Anderson; Marcus S Schamberger; Subhadra Shashidharan; Jeffrey P Jacobs; Marshall L Jacobs; Marko Boskovski; Jane W Newburger; Meena Nathan
Journal:  Cardiol Young       Date:  2020-05-08       Impact factor: 1.093

2.  Randomized Controlled Trials 1: Design.

Authors:  Bryan M Curtis; Brendan J Barrett; Patrick S Parfrey
Journal:  Methods Mol Biol       Date:  2021

3.  Current use and costs of electronic health records for clinical trial research: a descriptive study.

Authors:  Kimberly A Mc Cord; Hannah Ewald; Aviv Ladanie; Matthias Briel; Benjamin Speich; Heiner C Bucher; Lars G Hemkens
Journal:  CMAJ Open       Date:  2019-02-03

4.  Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice.

Authors:  Sheraz R Markar; Melody Ni; Suzanne S Gisbertz; Leonie van der Werf; Jennifer Straatman; Donald van der Peet; Miguel A Cuesta; George B Hanna; Mark I van Berge Henegouwen
Journal:  J Clin Oncol       Date:  2020-05-18       Impact factor: 44.544

Review 5.  Benchmarking Observational Analyses Against Randomized Trials: a Review of Studies Assessing Propensity Score Methods.

Authors:  Shaun P Forbes; Issa J Dahabreh
Journal:  J Gen Intern Med       Date:  2020-03-19       Impact factor: 5.128

6.  Leveraging big data to advance knowledge in pediatric heart failure and heart transplantation.

Authors:  Justin Godown; Michael Gaies; James D Wilkinson
Journal:  Transl Pediatr       Date:  2019-10

7.  Authors' Reply to Ravi Jandhyala's Comment on "Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments".

Authors:  Patricia McGettigan; Carla Alonso Olmo; Kelly Plueschke; Mireia Castillon; Daniel Zondag; Priya Bahri; Xavier Kurz; Peter G M Mol
Journal:  Drug Saf       Date:  2019-12       Impact factor: 5.606

Review 8.  Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Authors:  J Stephen Mikita; Jules Mitchel; Nicolle M Gatto; John Laschinger; James E Tcheng; Emily P Zeitler; Arlene S Swern; E Dawn Flick; Christopher Dowd; Theodore Lystig; Sara B Calvert
Journal:  Ther Innov Regul Sci       Date:  2020-06-22       Impact factor: 1.778

Review 9.  Secondary Use of Patient Data: Review of the Literature Published in 2016.

Authors:  D R Schlegel; G Ficheur
Journal:  Yearb Med Inform       Date:  2017-09-11

10.  Perspective: Limiting Dependence on Nonrandomized Studies and Improving Randomized Trials in Human Nutrition Research: Why and How.

Authors:  John F Trepanowski; John P A Ioannidis
Journal:  Adv Nutr       Date:  2018-07-01       Impact factor: 8.701

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