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

Sharon B. Love*, Fay Cafferty, Claire Snowdon, Karen Carty, Joshua Savage, Philip Pallmann, Lucy McParland, Louise Brown, Lindsey Masters, Francesca Schiavone, Dominic Hague, Stephen Townsend, Claire Amos, Annabelle South, Kate Sturgeon, Ruth Langley, Timothy Maughan, Nicholas James, Emma Hall, Sarah KernaghanJudith Bliss, Nick Turner, Andrew Tutt, Christina Yap, Charlotte Firth, Anthony Kong, Hisham Mehanna, Colin Watts, Robert Hills, Ian Thomas, Mhairi Copland, Sue Bell, David Sebag-Montefiore, Robert Jones, Mahesh K.B. Parmar, Matthew R. Sydes

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

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.

Original languageEnglish
Article number757
JournalTrials
Volume23
Issue number1
DOIs
Publication statusPublished - Dec 2022

Keywords

  • Basket trials
  • Complex innovative designs
  • Methodology
  • Multi-arm multi-stage trials
  • Platform protocols
  • Stratified medicine
  • Trial conduct
  • Umbrella trials

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