Review

. 2023 Mar 1;13(3):e068057.

doi: 10.1136/bmjopen-2022-068057.

Registry randomised trials: a methodological perspective

Dorota A Doherty^{1

2}, Steven Y C Tong^{3

4}, Jennifer Reilly^{5

6}, Jane Shrapnel⁷, Stephen McDonald^{8

9}, Susannah Ahern¹⁰, Ian Harris¹¹, Charmaine S Tam¹², Angela L Brennan¹⁰, Carol Hodgson¹⁰, Leonie Wilcox¹³, Anitha Balagurunathan¹⁴, Belinda E Butcher^{15

16}, Christopher M Reid^{17

18}

Affiliations

¹ UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia.
² Biostatistics and Research Design Unit, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.
³ The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
⁴ Menzies School of Health Research, Casuarina, Nothern Territory, Australia.
⁵ Anaesthesiology & Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
⁶ Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia.
⁷ The Sydney Children's Hospitals Network, Westmead, New South Wales, Australia.
⁸ Central Northern Adelaide Dialysis, The University of Adelaide, Adelaide, South Australia, Australia.
⁹ Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute Limited, Adelaide, South Australia, Australia.
¹⁰ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
¹¹ Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW, Sydney, New South Wales, Australia.
¹² Northern Clinical School, Centre for Translational Data Science, The University of Sydney, Sydney, New South Wales, Australia.
¹³ Australasian Bone Marrow Transplant Recipient Registry, St Vincent's Health Australia Ltd, Sydney, New South Wales, Australia.
¹⁴ Epidemiology, Alfred Health, Melbourne, Victoria, Australia.
¹⁵ WriteSource Medical Pty Ltd, Lane Cove, New South Wales, Australia.
¹⁶ University of New South Wales Faculty of Medicine, Sydney, New South Wales, Australia.
¹⁷ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia christopher.reid@curtin.edu.au.
¹⁸ School of Population Health, Curtin University, Perth, Western Australia, Australia.

PMID: 36858472
PMCID: PMC9980340
DOI: 10.1136/bmjopen-2022-068057

Review

Registry randomised trials: a methodological perspective

Dorota A Doherty et al. BMJ Open. 2023.

. 2023 Mar 1;13(3):e068057.

doi: 10.1136/bmjopen-2022-068057.

Authors

Affiliations

¹ UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia.
² Biostatistics and Research Design Unit, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.
³ The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
⁴ Menzies School of Health Research, Casuarina, Nothern Territory, Australia.
⁵ Anaesthesiology & Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
⁶ Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia.
⁷ The Sydney Children's Hospitals Network, Westmead, New South Wales, Australia.
⁸ Central Northern Adelaide Dialysis, The University of Adelaide, Adelaide, South Australia, Australia.
⁹ Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute Limited, Adelaide, South Australia, Australia.
¹⁰ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
¹¹ Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW, Sydney, New South Wales, Australia.
¹² Northern Clinical School, Centre for Translational Data Science, The University of Sydney, Sydney, New South Wales, Australia.
¹³ Australasian Bone Marrow Transplant Recipient Registry, St Vincent's Health Australia Ltd, Sydney, New South Wales, Australia.
¹⁴ Epidemiology, Alfred Health, Melbourne, Victoria, Australia.
¹⁵ WriteSource Medical Pty Ltd, Lane Cove, New South Wales, Australia.
¹⁶ University of New South Wales Faculty of Medicine, Sydney, New South Wales, Australia.
¹⁷ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia christopher.reid@curtin.edu.au.
¹⁸ School of Population Health, Curtin University, Perth, Western Australia, Australia.

PMID: 36858472
PMCID: PMC9980340
DOI: 10.1136/bmjopen-2022-068057

Abstract

Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way.

Keywords: biotechnology & bioinformatics; public health; statistics & research methods.

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Conflict of interest statement

Competing interests: CMR is funded through an NHMRC Principal Research Fellowship (GHT1136372). CH is funded by a National Heart Foundation Fellowship and an NHMRC Investigator Grant. JR is funded by an Australian Government Research Training Programme (RTP) Scholarship and a Monash University Graduate Excellence Scholarship.

Figures

**Figure 1**
Possible designs for registry randomised controlled trials. ICU, intensive care unit; RCT, randomised controlled trial.

**Figure 2**
Key pillars when considering embedding a registry randomised clinical trial. QA, quality assurance.

See this image and copyright information in PMC

References

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Registry randomised trials: a methodological perspective

Affiliations

Registry randomised trials: a methodological perspective

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources