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On Sample Size and Inference for Two‐Stage Adaptive Designs

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  • Qing Liu
  • George Y. H. Chi

Abstract

Summary. Proschan and Hunsberger (1995, Biometrics51, 1315–1324) proposed a two‐stage adaptive design that maintains the Type I error rate. For practical applications, a two‐stage adaptive design is also required to achieve a desired statistical power while limiting the maximum overall sample size. In our proposal, a two‐stage adaptive design is comprised of a main stage and an extension stage, where the main stage has sufficient power to reject the null under the anticipated effect size and the extension stage allows increasing the sample size in case the true effect size is smaller than anticipated. For statistical inference, methods for obtaining the overall adjusted p‐value, point estimate and confidence intervals are developed. An exact two‐stage test procedure is also outlined for robust inference.

Suggested Citation

  • Qing Liu & George Y. H. Chi, 2001. "On Sample Size and Inference for Two‐Stage Adaptive Designs," Biometrics, The International Biometric Society, vol. 57(1), pages 172-177, March.
    • Handle: RePEc:bla:biomet:v:57:y:2001:i:1:p:172-177
    DOI: 10.1111/j.0006-341X.2001.00172.x
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    References listed on IDEAS

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    1. 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.
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    Cited by:

    1. Guosheng Yin & Yu Shen, 2005. "Adaptive Design and Estimation in Randomized Clinical Trials with Correlated Observations," Biometrics, The International Biometric Society, vol. 61(2), pages 362-369, June.
    2. Werner Brannath & Peter Bauer, 2004. "Optimal Conditional Error Functions for the Control of Conditional Power," Biometrics, The International Biometric Society, vol. 60(3), pages 715-723, September.
    3. Yi Cheng & Yu Shen, 2004. "Estimation of a Parameter and Its Exact Confidence Interval Following Sequential Sample Size Reestimation Trials," Biometrics, The International Biometric Society, vol. 60(4), pages 910-918, December.
    4. Uttam Bandyopadhyay & Atanu Biswas & Rahul Bhattacharya, 2010. "A covariate‐adjusted adaptive design for two‐stage clinical trials with survival data," Statistica Neerlandica, Netherlands Society for Statistics and Operations Research, vol. 64(2), pages 202-226, May.
    5. Lingyun Liu & Sam Hsiao & Cyrus R. Mehta, 2018. "Efficiency Considerations for Group Sequential Designs with Adaptive Unblinded Sample Size Re-assessment," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 10(2), pages 405-419, August.
    6. 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.

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