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<p>Adaptive designs offer great flexibility to clinical trial modifications based on interim results and external information. In this paper, we consider a complex innovative design that combines Sequential Parallel Comparison Design (SPCD) and Pick-the-Winner design (PWD). SPCD has been developed to identify individuals with high placebo responses and exclude them from the follow-up experiments. In this way, SPCD aims to mitigate the impact of placebo responses on clinical trials. On the other hand, PWD aims to solve the problem of selecting the most promising treatment or determining the appropriate dose of a drug in seamless Phase II/III clinical trials. By combining SPCD and PWD, adaptive SPCD extends the traditional two-arm SPCD to multi-arm setting and simultaneously provides treatment selections. In this paper, we propose hypothesis testing procedures that strongly control Type I error for adaptive SPCD. A simulation study is conducted to compare the operating characteristics of adaptive SPCD with existing designs.</p>

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Adaptive Sequential Parallel Comparison Designs with Treatment Selection for Continuous Outcomes

  • 期刊论文

  • 发表日期：

    2025年6月14日

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  • Samuel S. Wu,
  • A. Adam Ding,
  • Yuting Yang,
  • Natalie DelRocco,
  • Guogen Shan

摘要

Adaptive designs offer great flexibility to clinical trial modifications based on interim results and external information. In this paper, we consider a complex innovative design that combines Sequential Parallel Comparison Design (SPCD) and Pick-the-Winner design (PWD). SPCD has been developed to identify individuals with high placebo responses and exclude them from the follow-up experiments. In this way, SPCD aims to mitigate the impact of placebo responses on clinical trials. On the other hand, PWD aims to solve the problem of selecting the most promising treatment or determining the appropriate dose of a drug in seamless Phase II/III clinical trials. By combining SPCD and PWD, adaptive SPCD extends the traditional two-arm SPCD to multi-arm setting and simultaneously provides treatment selections. In this paper, we propose hypothesis testing procedures that strongly control Type I error for adaptive SPCD. A simulation study is conducted to compare the operating characteristics of adaptive SPCD with existing designs.