MRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
The Institute of Cancer Research, London, SW7 3RP, UK.
Trials. 2022 Sep 6;23(1):757. doi: 10.1186/s13063-022-06680-4.
Late-phase platform protocols (including basket, umbrella, multi-arm multi-stage (MAMS), and master protocols) are generally agreed to be more efficient than traditional two-arm clinical trial designs but are not extensively used. We have gathered the experience of running a number of successful platform protocols together to present some operational recommendations.
Representatives of six UK clinical trials units with experience in running late-phase platform protocols attended a 1-day meeting structured to discuss various practical aspects of running these trials. We report and give guidance on operational aspects which are either harder to implement compared to a traditional late-phase trial or are specific to platform protocols.
We present a list of practical recommendations for trialists intending to design and conduct late-phase platform protocols. Our recommendations cover the entire life cycle of a platform trial: from protocol development, obtaining funding, and trial set-up, to a wide range of operational and regulatory aspects such as staffing, oversight, data handling, and data management, to the reporting of results, with a particular focus on communication with trial participants and stakeholders as well as public and patient involvement.
Platform protocols enable many questions to be answered efficiently to the benefit of patients. Our practical lessons from running platform trials will support trial teams in learning how to run these trials more effectively and efficiently.
后期平台方案（包括篮子、伞式、多臂多阶段（MAMS）和主方案）通常被认为比传统的双臂临床试验设计更有效，但尚未广泛应用。我们汇集了一些成功运行平台方案的经验，提出了一些操作建议。
六位具有运行后期平台方案经验的英国临床试验单位代表参加了为期一天的会议，会议的结构旨在讨论这些试验的各个实际方面。我们报告并提供了有关操作方面的指导，这些方面与传统的后期试验相比实施起来更困难，或者是专门针对平台方案的。
我们为打算设计和进行后期平台方案的试验人员提出了一系列实用建议。我们的建议涵盖了平台试验的整个生命周期：从方案制定、获得资金和试验设立，到广泛的操作和监管方面，如人员配备、监督、数据处理和数据管理，再到结果报告，特别关注与试验参与者和利益相关者的沟通以及公众和患者的参与。
平台方案使许多问题能够得到高效解决，从而使患者受益。我们从运行平台试验中获得的实际经验将支持试验团队学习如何更有效地运行这些试验。
