Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units.
Date
2022-09-06ICR Author
Author
Love, SB
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, MKB
Sydes, MR
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
Basket trials
Complex innovative designs
Methodology
Multi-arm multi-stage trials
Platform protocols
Stratified medicine
Trial conduct
Umbrella trials
Data Management
Humans
Research Design
United Kingdom
Research team
Clin Trials & Stats Unit
Language
eng
Date accepted
2022-08-20
License start date
2022-09-06
Citation
Trials, 2022, 23 (1), pp. 757 -
Publisher
BMC
Except where otherwise noted, this item's license is described
as
https://creativecommons.org/publicdomain/zero/1.0/
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