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Review
Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era
  1. Troels Yndigegn1,
  2. Robin Hofmann2,
  3. Tomas Jernberg3,
  4. Chris P Gale4
  1. 1 Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden
  2. 2 Department of Clinical Science and Education, Division of Cardiology, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden
  3. 3 Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden
  4. 4 Clinical and Population Sciences Department, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
  1. Correspondence to Professor Chris P Gale, MRC Bioinformatics Centre, Level 11 Worsely building, Clarendon Road, University of Leeds, LS2 9JT, UK; c.p.gale{at}leeds.ac.uk

Abstract

Randomised clinical trials are the gold standard for testing the effectiveness of clinical interventions. However, increasing complexity and associated costs may limit their application in the investigation of key cardiovascular knowledge gaps such as the re-evaluation of generic pharmacotherapies. The registry-based randomised clinical trial (RRCT) leverages data sampling from nationwide quality registries to facilitate high participant inclusion rates at comparably low costs and, therefore, may offer a mechanism by which such clinical questions may be answered. To date, a number of studies have been conducted using such trial designs, but uncritical use of the RRCT design may lead to erroneous conclusions. The current review provides insights into the strengths and weaknesses of the RRCT, as well as provides an exploratory example of how a trial may be designed to test the long-term effectiveness of beta blockers in patients with myocardial infarction who have preserved left ventricular systolic function.

  • Study Design
  • Electronic Medical Records
  • Pharmacology
  • Acute Myocardial Infarction

https://doi.org/10.1136/heartjnl-2017-312322

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    Footnotes

    • Contributors All authors have provided ideas for the manuscript. The first author has prepared the manuscript together with the last author. All authors have commented and significantly revised the manuscript. All authors have read and approved the final version of the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No unpublished data are available owing to the nature of the paper.