Cited by 331Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsAdvanced Causal Inference Techniques

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Registry-based randomized clinical trials—a new clinical trial paradigm

James, Stefan, Rao, Sunil V., Granger, Christopher B.·2015·Nature Reviews Cardiology

DOI 10.1038/nrcardio.2015.33

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Abstract

Randomized clinical trials provide the foundation of clinical evidence to guide physicians in their selection of treatment options. Importantly, randomization is the only reliable method to control for confounding factors when comparing treatment groups. However, randomized trials have limitations, including the increasingly prohibitive costs of conducting adequately powered studies. Local and national regulatory requirements, delays in approval, and unnecessary trial processes have led to increased costs and decreased efficiency. Another limitation is that clinical trials involve selected patients who are treated according to protocols that might not represent real-world practice. A possible solution is registry-based randomized clinical trials. By including a randomization module in a large inclusive clinical registry with unselected consecutive enrolment, the advantages of a prospective randomized trial can be combined with the strengths of a large-scale all-comers clinical registry. We believe that prospective registry-based randomized clinical trials are a powerful tool for conducting studies efficiently and cost-effectively.

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Crossref · 10.1038/nrcardio.2015.33

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Authors: James, S., Rao, S. V., & Granger, C. B.
Affiliations: Uppsala University Hospital (SE)
Duke Medical Center (US)
Corresponding author: James, Stefan
ORCID: James, Stefan
Rao, Sunil V.
Granger, Christopher B.
Venue: Nature Reviews Cardiology
Publisher: Springer Science and Business Media LLC
Published: 2015-03-17
Volume: 12
Issue: 5
Pages: 312-316
ISSN: 1759-5002 (ISSN-L)
1759-5010
DOI: 10.1038/nrcardio.2015.33
OpenAlex: W2056697517
Cited by: 331
References: 29
Citations by year: 2026: 12 · 2025: 29 · 2024: 33 · 2023: 34 · 2022: 32 · 2021: 46 · 2020: 33 · 2019: 36 · 2018: 35 · 2017: 20 · 2016: 17 · 2015: 3
FWCI: 4.19
Type: journal article
Language: en
Open access: closed
Licence: www.springer.com/tdm (tdm)
Locations: Nature Reviews Cardiology (publishedVersion)
PubMed (publishedVersion)
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
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: clinical registries, randomization, confounding adjustment, real-world practice, trial design limitations
MeSH terms: Cardiology, Humans, Registries, Research Design, Randomized Controlled Trials as Topic

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Registry-based randomized clinical trials—a new clinical trial paradigm

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