Registry randomised trials: a methodological perspective
Dorota A. Doherty, Steven Y. C. Tong, Jennifer Reilly, Jane Shrapnel, Stephen P. McDonald, Susannah Ahern, Ian A. Harris, Charmaine S. Tam, Angela L Brennan, Carol Hodgson, Leonie Wilcox, Anitha Balagurunathan, Belinda Butcher, Christopher M. Reid
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.