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Abstract:
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With the increasing complexity of confirmatory clinical trials, more than one investigational agent is involved with multi-arm study design. One of the challenges is the substantial large sample size usually required to explore each investigational agent treatment, to demonstrate the contribution of components. To overcome the above challenge, factorial design provides one possibility that minimizes the sample size increasing over 2-arm study to detect each individual treatment. Proportional hazard ratio is usually assumed when examining the whole regimen. However, with more established fist-line treatment in some oncologic indications, induction and maintenance studies are designed to provide maintenance treatment options for patients. We propose a modified factorial for induction and maintenance (MFIM), where we can examine the main treatment effects by pulling treatment arms while explore the interaction effect by individual arm comparison. Simulation results will be provided to show the performance of the proposed MFIM. Moreover, various scenarios will be simulated to illustrate the contribution of components.
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