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Trial Design

BEAT-Calci is an adaptive, platform, randomised controlled trial, involving multiple interventions spanning several domains of therapeutic care. Click the tabs below to find out more information about the design of this study. 

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.

For more information on adaptive trials and how they differ from traditional clinical trial designs, see the video below or visit the Australian Clinical Trials Alliance website for additional adaptive trial resources.