TY - JOUR
T1 - Registry randomised trials
T2 - a methodological perspective
AU - Doherty, Dorota A.
AU - Tong, Steven Y.C.
AU - Reilly, Jennifer
AU - Shrapnel, Jane
AU - McDonald, Stephen
AU - Ahern, Susannah
AU - Harris, Ian
AU - Tam, Charmaine S.
AU - Brennan, Angela L.
AU - Hodgson, Carol
AU - Wilcox, Leonie
AU - Balagurunathan, Anitha
AU - Butcher, Belinda E.
AU - Reid, Christopher M.
N1 - Funding Information:
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.
Funding Information:
This work was supported by an Australian Government Medical Research Future Fund grant through the 2017 Lifting Clinical Trials and Registries Capacity—Clinical Trials Networks Programme.
Publisher 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.
PY - 2023/3/1
Y1 - 2023/3/1
N2 - 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.
AB - 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.
KW - biotechnology & bioinformatics
KW - public health
KW - statistics & research methods
UR - http://www.scopus.com/inward/record.url?scp=85149427213&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-068057
DO - 10.1136/bmjopen-2022-068057
M3 - Article
C2 - 36858472
AN - SCOPUS:85149427213
SN - 2044-6055
VL - 13
JO - BMJ open
JF - BMJ open
IS - 3
M1 - e068057
ER -