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Cited by 24Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsElectronic Health Records Systems

Registry-based randomised controlled trials: conduct, advantages and challenges—a systematic review

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Shiely, Frances, O Shea, Niamh, Murphy, Ellen, Eustace, Joseph·2024·Trials
DOI 10.1186/s13063-024-08209-3PMC PMC11165819
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Abstract

Background: Registry-based randomised controlled trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large-scale registries to facilitate key clinical trial procedures including recruitment, randomisation and the collection of outcome data. Whilst the practice of utilising registries to support the conduct of randomised trials is increasing, the use of the registries within rRCTs is inconsistent. The purpose of this systematic review is to explore the conduct of rRCTs using a patient registry to facilitate trial recruitment and the collection of outcome data, and to discuss the advantages and challenges of rRCTs. Methods: A systematic search of the literature was conducted using five databases from inception to June 2020: PubMed, Embase (through Ovid), CINAHL, Scopus and the Cochrane Controlled Register of Trials (CENTRAL). The search strategy comprised of MESH terms and key words related to rRCTs. Study selection was performed independently by two reviewers. A risk of bias for each study was completed. A narrative synthesis was conducted. Results: A total 47,862 titles were screened and 24 rRCTs were included. Eleven rRCTs (45.8%) used more than one registry to facilitate trial conduct. Six rRCTs (25%) randomised participants via a specific randomisation module embedded within a registry. Recruitment ranged between 209 to 106,000 participants. Advantages of rRCTs are recruitment efficiency, shorter trial times, cost effectiveness, outcome data completeness, smaller carbon footprint, lower participant burden and the ability to conduct multiple trials from the same registry. Challenges are data collection/management, quality assurance issues and the timing of informed consent. Conclusions: Optimising the design of rRCTs is dependent on the capabilities of the registry. New registries should be designed and existing registries reviewed to enable the conduct of rRCTs. At all times, data management and quality assurance of all registry data should be given key consideration. We suggest the inclusion of the term ‘registry-based’ in the title of all rRCT manuscripts and a clear simple breakdown of the registry-based conduct of the trial in the abstract to facilitate indexing in the major databases.

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  • The costs of such trials are typically much lower than those of traditional RCTs.

    “The costs of such trials are typically much lower than those of traditional RCTs (Shiely et al. 2024).”

    From Dental Research in the Digital Age: The Registry-Based Clinical Trial. (2026) · cites this paper as Shiely et al. 2024

    The Discussion says registry-based methods can reduce trial costs, but it also says the review included no cost-effectiveness comparison with a traditional RCT and notes considerable initial setup costs. The source therefore supports potential savings, not the claim that these trials typically cost much less than traditional RCTs. (LLM, conf=0.88)

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Cited by

Sorted by citations

Authors
Shiely, F., O Shea, N., Murphy, E., & Eustace, J.
Affiliations
  • University College Cork (IE)
  • Cork University Hospital (IE)
Corresponding author
Shiely, Frances
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2024-06-11
Volume
25
Issue
1
Pages
375-375
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-024-08209-3
PMC
PMC11165819
OpenAlex
W4399514853
Cited by
24
References
3
Citations by year
2026: 14 · 2025: 6 · 2024: 4
FWCI
1.55
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
Health Research Board (HRB-TMRN-2017-001.)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
Keywords
patient registry, trial recruitment, randomization, outcome data collection, pragmatic trials, quality assurance, informed consent, registry design
MeSH terms
Humans, Registries, Research Design, Randomized Controlled Trials as Topic, Patient Selection, Pragmatic Clinical Trials as Topic

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