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

Love, S. B. et al. (2022) Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units. Trials, 23, 757. (doi: 10.1186/s13063-022-06680-4) (PMID:36068599) (PMCID:PMC9449272)

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: Articles
• Additional Information: Funding Sharon Love Matthew R Sydes, Annabelle South, Fay Caferty, Lindsey Masters, Francesca Schiavone, Stephen Townsend, Claire Amos, and Kate Sturgeon were funded by MRC grant MC_UU_00004/08. Ruth Langley, Mahesh Parmar, and Louise Brown by MC_UU_00004/01 MC_UU_00004/02. The Centre for Trials Research receives infrastructure funding from Health and Care Research Wales and Cancer Research UK which funded the input from Philip Pallmann and Ian Thomas. The Cancer Research UK Clinical Trials Unit (CRCTU) is supported by a core programme grant from Cancer Research UK grant number C22436/A25354 which funded the input from Christina Yap and Charlotte Firth.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Copland, Professor Mhairi and Jones, Professor Robert and Carty, Mrs Karen
• Authors: Love, S. B., Cafferty, F., Snowdon, C., Carty, K., Savage, J., Pallmann, P., McParland, L., Brown, L., Masters, L., Schiavone, F., Hague, D., Townsend, S., Amos, C., South, A., Sturgeon, K., Langley, R., Maughan, T., James, N., Hall, E., Kernaghan, S., Bliss, J., Turner, N., Tutt, A., Yap, C., Firth, C., Kong, A., Mehanna, H., Watts, C., Hills, R., Thomas, I., Copland, M., Bell, S., Sebag-Montefiore, D., Jones, R., Parmar, M. K. B., and Sydes, M. R.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: Trials
• Publisher: BMC
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Published Online: 06 September 2022
• Copyright Holders: Copyright © The Author(s) 2022
• First Published: First published in Trials 23: 757
• Publisher Policy: Reproduced under a Creative Commons license