Mini Review
Adaptive Design and the Estimand Framework
Received Date: February 22, 2019; Published Date: March 13, 2019
Abstract
Adaptive designs allow prospectively planned modifications of a study without undermining the integrity and validity of the study. The draft ICH E9 addendum recommends the estimand framework in design, conduct, analysis, and interpretation of clinical trials for assessment of effectiveness of therapies. Herein, we discuss the possible impact and scientific implications when incorporating the estimand framework to adaptively designed clinical trials. It is hoped that this will elucidate how this framework provides a language for discussing relevant questions, related to the attributes of the estimand, that may arise from study adaptations.
Keywords: Enrichment design; Biomarker; Adaptive design; Intercurrent events; Estimand; Sample size reassessment; Group sequential design
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