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

Love, Sharon B., Cafferty, Fay, Snowdon, Claire, Carty, Karen, Savage, Joshua, Pallmann, Philip ORCID: https://orcid.org/0000-0001-8274-9696, 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 and Sydes, Matthew R 2022. Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units. Trials 23 , 757. 10.1186/s13063-022-06680-4

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Additional Information:	This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Publisher:	BioMed Central
Date of First Compliant Deposit:	7 September 2022
Date of Acceptance:	20 August 2022
Last Modified:	28 Jun 2024 18:22
URI:	https://orca.cardiff.ac.uk/id/eprint/152396

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