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Abstract:
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Adaptive designs have been used more and more in clinical studies to expedite the drug development process. Both regulatory agency and industry have provided guidance on adaptive designs, established adaptive design working groups. We will focus on two-stage phase II/III adaptive designs. In phase II studies, typically several doses or regimens of a new drug can be explored. Based on the phase II data the drug development process may be stopped due to futility or the promising treatments can be selected to continue for phase III study. The decision process in the interim analysis is usually complex and sample size-re-estimation can be done. A case example will be presented. The clinical and statistical components, including the study design, study population, selections of endpoints with adaptive treatment selection at interim analysis for multiple comparisons to control will be discussed. EAST software will be used to implement the adaptive design and interim monitoring. At interim analysis, the sample size re-estimation will be done based on the conditional power decisions. We will share our experiences and recommendations about how to overcome the challenges and issues.
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