Asymmetric Group Sequential Designs under Fractional Brownian Motion

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Group sequential designs are important tools for clinical trials with interim monitoring plans. Recently, asymmetric group sequential designs with non binding rules are applied to clinical trials of many disease areas including oncology. In this article, we study boundary calculations and sample size determination for these designs with interim statistics under both standard Brownian motion (BM) and fractional Brownian motion (FBM). Power family spending functions, including Pocock and O'Brien-Fleming design types, are considered for these calculations. We use clinical trial examples to show how to design such trials under BM and FBM for efficacy and futility monitoring.