An adaptive trial is a novel trial design in which key trial characteristics can be adapted over time, based on the accumulating data, using pre-specified rules. There are many different possible adaptations that can be pre-specified in an adaptive trial. Examples include but are not limited to; the addition or removal of an intervention arm and response adaptive randomisation. As a result, adaptive trials typically require considerable pre-trial evaluation through simulation to assess the consequences of patient selection and stratification, organisation of study arms, within-trial adaptations and overarching statistical modelling.
A platform trial evaluates multiple treatments and hypotheses simultaneously within a single overarching trial infrastructure, in a perpetual manner. Platform trials sometimes use a ‘modular’ protocol which allow interventions, domains, and countries/regions to be introduced and adapted over time to meet the needs of the trial.
The BEAT-Calci trial is designed to test multiple interventions across different therapeutic care domains and uses an adaptive, platform, randomised controlled trial design.
