Adaptive randomised control trials (RCTs) in stroke
Presented by Professor Leonid Churilov
We discuss some aspects of design and analysis of two hyperacute stroke RCTs where we used adaptive sample size re-estimation procedure proposed by Mehta and Pocock. Extend IA (published in NEJM) compared the effectiveness of intra-arterial clot removal vs stroke thrombolysis alone and was one of the four pivotal RCTs that changed international clinical practice, while Extend IA TNK compared the effect of two different thrombolytic agents after ischaemic stroke. We also discuss the proposed covariate-adjusted response-adaptive design for AVERT-DOSE – a recently funded RCT in stroke rehabilitation with a complex multi-faceted physiotherapy intervention.