Registry randomised trials: a methodological perspective.
biotechnology & bioinformatics
public health
statistics & research methods
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
01 03 2023
01 03 2023
Historique:
entrez:
1
3
2023
pubmed:
2
3
2023
medline:
4
3
2023
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 36858472
pii: bmjopen-2022-068057
doi: 10.1136/bmjopen-2022-068057
pmc: PMC9980340
doi:
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e068057Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
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.
Références
Trials. 2017 Dec 21;18(1):610
pubmed: 29268758
Trials. 2019 Feb 4;20(1):100
pubmed: 30717778
Trials. 2015 Nov 03;16:495
pubmed: 26530985
Eur Heart J. 2010 Mar;31(5):525-9
pubmed: 20093258
PLoS One. 2017 Sep 8;12(9):e0183667
pubmed: 28886607
Eur J Pediatr. 2022 Aug;181(8):3207-3210
pubmed: 35579708
N Engl J Med. 2013 Oct 24;369(17):1579-81
pubmed: 23991657
Transplantation. 2009 Jun 27;87(12):1877-83
pubmed: 19543068
BMC Health Serv Res. 2018 Oct 20;18(1):802
pubmed: 30342511
Lancet. 2022 Jul 30;400(10349):359-368
pubmed: 35908569
JAMA. 2020 Feb 18;323(7):616-626
pubmed: 31950977
Drug Saf. 2019 Nov;42(11):1343-1351
pubmed: 31302896
Transplantation. 2012 Jul 27;94(2):152-8
pubmed: 22728292
Eur J Cancer. 2017 Nov;86:178-185
pubmed: 28992561
Anaesth Intensive Care. 2020 May;48(3):203-212
pubmed: 32345029
BMJ Open. 2017 Feb 17;7(2):e013770
pubmed: 28213601
Am Heart J. 2010 Dec;160(6):1042-8
pubmed: 21146656
BMC Med Res Methodol. 2017 Jul 10;17(1):95
pubmed: 28693507
BMJ Open. 2019 Sep 5;9(9):e032165
pubmed: 31492797
Am J Public Health. 2004 Mar;94(3):416-22
pubmed: 14998805
J R Soc Med. 2015 May;108(5):192-8
pubmed: 26022551
JAMA. 2012 Nov 7;308(17):1743-4
pubmed: 23117771
BMJ Open. 2017 Aug 18;7(8):e015867
pubmed: 28821519
Lung Cancer. 2014 Mar;83(3):347-55
pubmed: 24418526
Trials. 2020 Jun 22;21(1):552
pubmed: 32571382
Heart. 2012 Sep;98(18):1329-31
pubmed: 22591738
Transplant Direct. 2022 Nov 04;8(12):e1399
pubmed: 36479278
J Clin Epidemiol. 2016 Dec;80:16-24
pubmed: 27555082
Heart. 2018 Oct;104(19):1562-1567
pubmed: 29666176
Lancet. 2022 Jul 16;400(10347):161-169
pubmed: 35779553
Nat Rev Cardiol. 2015 May;12(5):312-6
pubmed: 25781411