Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units

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.ResultsWe 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.DiscussionPlatform 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.
Source: Trials - Category: Research Source Type: clinical trials