UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia.
Biostatistics and Research Design Unit, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.
BMJ Open. 2023 Mar 1;13(3):e068057. doi: 10.1136/bmjopen-2022-068057.
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.
注册随机临床试验（RRCTs）有可能为重要的临床问题提供实用的答案。RRCT 可以嵌入到大的基于人群的登记处或较小的单一地点登记处，与传统的随机对照试验相比，以更低的成本提供及时的答案。RRCT 除了传统的个体水平随机试验外，还可以采用多种形式，包括平行组试验、平台或适应性试验、集群随机试验和集群随机阶梯式试验。从实施的角度来看，最初将 RRCT 嵌入到成熟的登记处是有利的，因为这些登记处通常已经解决了终点验证和裁决的任何问题。随着数据链接和数据质量的进步，RRCT 可以在以实用且具有成本效益的方式回答临床问题方面发挥重要作用。
