Title: Responder Analyses and the Assessment of a Clinically Relevant Treatment Effect
نویسنده
چکیده
Author's response to reviews: I have made some minor modifications to the previously submitted versions based on comments from Assistant Editor Claire Owen. These changes are related to style and organization, not to content.
منابع مشابه
Responder analyses and the assessment of a clinically relevant treatment effect
Ideally, a clinical trial should be able to demonstrate not only a statistically significant improvement in the primary efficacy endpoint, but also that the magnitude of the effect is clinically relevant. One proposed approach to address this question is a responder analysis, in which a continuous primary efficacy measure is dichotomized into "responders" and "non-responders." In this paper we ...
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Ideally, a clinical trial should be able to demonstrate not only a statistically significant improvement in the primary efficacy endpoint, but also that the magnitude of the effect is clinically relevant. One proposed approach to address this question is a responder analysis, in which a continuous primary efficacy measure is dichotomized into "responders" and "non-responders." In this paper we ...
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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 definit...
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