Registry randomised trials: a methodological perspective

Author:

Doherty Dorota A,Tong Steven Y C,Reilly JenniferORCID,Shrapnel Jane,McDonald Stephen,Ahern Susannah,Harris Ian,Tam Charmaine S,Brennan Angela L,Hodgson Carol,Wilcox Leonie,Balagurunathan Anitha,Butcher Belinda EORCID,Reid Christopher M

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.

Funder

Australian Government Medical Research Future Fund grant through the 2017 Lifting Clinical Trials and Registries Capacity - Clinical Trials Networks Program

Publisher

BMJ

Subject

General Medicine

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