The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes

Trials: April 11, 2013

Background

Traditionally in acute stroke clinical trials, the primary clinical outcome employed is a dichotomized modified Rankin Scale (mRS). New statistical methods, such as responder analysis, are being used in stroke studies to address the concern that baseline prognostic variables, such as stroke severity, impact the likelihood of a successful outcome. Responder analysis allows the definition of success to vary according to baseline prognostic variables, producing a more clinically relevant insight into the actual effect of investigational treatments. It is unclear whether or not statistical analyses should adjust for prognostic variables when responder analysis is used, as the outcome already takes these prognostic variables into account. This research aims to investigate the effect of covariate adjustment in the responder analysis framework in order to determine the appropriate analytic method. Read more