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Registry-based randomised controlled trials: conduct, advantages and challenges-a systematic review
Frances Shiely1,2, Niamh O Shea3,4, Ellen Murphy3,4
1Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, 4th Floor Western Gateway Building, Western Road, Cork, Ireland. f.shiely@ucc.ie.
Trials
|June 11, 2024
Summary
Registry-based randomized controlled trials (rRCTs) leverage patient registries for efficient recruitment and data collection. Optimizing registry design and data management is key to maximizing the benefits of these pragmatic trials.
Area of Science:
- Clinical Trials Methodology
- Health Informatics
- Public Health Research
Background:
- Registry-based randomized controlled trials (rRCTs) utilize existing patient data within registries to streamline clinical trial processes.
- While the use of registries in randomized trials is growing, their application within rRCTs remains inconsistent.
- This systematic review examines the conduct of rRCTs using patient registries for recruitment and outcome data collection, exploring associated advantages and challenges.
Purpose of the Study:
- To systematically review and explore the conduct of registry-based randomized controlled trials (rRCTs).
- To identify and discuss the advantages and challenges associated with using patient registries in rRCTs.
- To provide recommendations for optimizing the design and conduct of future rRCTs.
Main Methods:
- A comprehensive systematic literature search was performed across five major databases (PubMed, Embase, CINAHL, Scopus, CENTRAL) from inception to June 2020.
- Search strategy included MESH terms and keywords related to registry-based randomized controlled trials.
- Study selection and risk of bias assessment were conducted independently by two reviewers, followed by a narrative synthesis of findings.
Main Results:
- The review included 24 registry-based randomized controlled trials (rRCTs) from 47,862 screened titles.
- Eleven rRCTs (45.8%) utilized multiple registries, and six (25%) employed registry-embedded randomization modules.
- Reported advantages include enhanced recruitment efficiency, reduced trial duration, cost-effectiveness, complete outcome data, and lower participant burden; challenges involve data management, quality assurance, and informed consent timing.
Conclusions:
- The effectiveness of registry-based randomized controlled trials (rRCTs) is significantly influenced by the capabilities of the underlying patient registries.
- Future registry development and existing registry reviews should prioritize features enabling robust rRCT conduct.
- Consistent emphasis on data management and quality assurance is crucial, alongside clear reporting of registry-based methods in publications to improve database indexing.
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