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A Note of Adaptive Design in Clinical Trials

Author

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  • Jingjing Chen

    (Director of Statistics and Quantitative Science, Takeda Pharmaceuticals, USA)

Abstract

During the past decades, adaptive design in clinical trials has gained more and more attention in the industry and academia, not only for early phase/exploratory trials but also for confirmatory trials. Adaptive design is also endorsed by the regulatory agencies, if performed with care [1-2]. This paper provides an overview of the basic concepts of adaptive design in clinical trials, including the adaptation rules, types of adaptive design, and statistical principles of data analysis as well as the Type I error control. Operational hurdles and regulatory challenges are discussed as well.

Suggested Citation

  • Jingjing Chen, 2019. "A Note of Adaptive Design in Clinical Trials," Biostatistics and Biometrics Open Access Journal, Juniper Publishers Inc., vol. 9(5), pages 107-111, August.
    • Handle: RePEc:adp:jbboaj:v:9:y:2019:i:5:p:107-111
    DOI: 10.19080/BBOAJ.2019.09.555772
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    References listed on IDEAS

    as
    1. Walter Lehmacher & Gernot Wassmer, 1999. "Adaptive Sample Size Calculations in Group Sequential Trials," Biometrics, The International Biometric Society, vol. 55(4), pages 1286-1290, December.
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    4. Hans-Helge Müller & Helmut Schäfer, 2001. "Adaptive Group Sequential Designs for Clinical Trials: Combining the Advantages of Adaptive and of Classical Group Sequential Approaches," Biometrics, The International Biometric Society, vol. 57(3), pages 886-891, September.
    5. Yu Shen & Lloyd Fisher, 1999. "Statistical Inference for Self-Designing Clinical Trials with a One-Sided Hypothesis," Biometrics, The International Biometric Society, vol. 55(1), pages 190-197, March.
    6. Liu Q. & Proschan M.A. & Pledger G.W., 2002. "A Unified Theory of Two-Stage Adaptive Designs," Journal of the American Statistical Association, American Statistical Association, vol. 97, pages 1034-1041, December.
    7. Carl-Fredrik Burman & Christian Sonesson, 2006. "Are Flexible Designs Sound?," Biometrics, The International Biometric Society, vol. 62(3), pages 664-669, September.
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    Full references (including those not matched with items on IDEAS)

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