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

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 prese

SUBMITTER: Love SB 

PROVIDER: S-EPMC9449272 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature