1 - 7 of 7 Chapters
[In this chapter, we provide an overview of several emerging statistical challenges in recent clinical trials. These include multiple endpoints, non-inferiority designs, and adaptive designs.]
[We discuss group-sequential designs for early efficacy stopping in clinical trials with two outcomes as co-primary endpoints, i.e., trials designed to evaluate whether the test intervention is superior to the control on all primary endpoints. We discuss two outcome scale situations: (i) when...
[Clinical trial design requires assumptions. Prior data often serve as the basis for these assumptions. However, prior data may be limited or an inaccurate indication of future data. This may result in trials that are over-/under-powered. Interim analyses provide opportunities to evaluate the...
[We discuss group-sequential designs for early efficacy or futility stopping in superiority clinical trials with multiple co-primary endpoints. We discuss several decision-making frameworks for evaluating efficacy or futility based on boundaries using group-sequential methodology. We incorporate...
[In this chapter, we provide an overview of the fundamental concepts and technical details for group-sequential designs for clinical trials comparing two interventions based on two primary endpoints. In this situation, there are many procedures for controlling the Type I error rate. We discuss...
[We discuss group-sequential three-arm non-inferiority (NI) clinical trials, i.e., trials that include a test intervention as well as active and placebo controls for evaluating both assay sensitivity and NI. We extend two existing approaches, the fixed margin and fraction approaches, to a...
[Chapters 1–6 focus on selected emerging statistical issues in clinical trials. This work provides a foundation for designing randomized trials with other design features. This includes clinical trials with more than two interventions (e.g., dose-selection clinical trials): trials with...
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