Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units
Author:
Love Sharon B.ORCID, Cafferty Fay, Snowdon Claire, Carty Karen, Savage Joshua, Pallmann Philip, McParland Lucy, Brown Louise, Masters Lindsey, Schiavone Francesca, Hague Dominic, Townsend Stephen, Amos Claire, South Annabelle, Sturgeon Kate, Langley Ruth, Maughan Timothy, James Nicholas, Hall Emma, Kernaghan Sarah, Bliss Judith, Turner Nick, Tutt Andrew, Yap Christina, Firth Charlotte, Kong Anthony, Mehanna Hisham, Watts Colin, Hills Robert, Thomas Ian, Copland Mhairi, Bell Sue, Sebag-Montefiore David, Jones Robert, Parmar Mahesh K. B., Sydes Matthew R.
Abstract
Abstract
Background
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.
Methods
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.
Results
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.
Discussion
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.
Funder
Medical Research Council Health and Care Research Wales Cancer Research UK
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
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