IDEAS home Printed from https://ideas.repec.org/a/bla/biomet/v57y2001i1p172-177.html
   My bibliography  Save this article

On Sample Size and Inference for Two‐Stage Adaptive Designs

Author

Listed:
  • 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
    as

    Download full text from publisher

    File URL: https://doi.org/10.1111/j.0006-341X.2001.00172.x
    Download Restriction: no
    File URL: https://libkey.io/10.1111/j.0006-341X.2001.00172.x?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    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.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    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. 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.
    3. Martin Posch & Peter Bauer, 2000. "Interim Analysis and Sample Size Reassessment," Biometrics, The International Biometric Society, vol. 56(4), pages 1170-1176, December.
    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. Christopher Jennison & Bruce W. Turnbull, 2006. "Discussions," Biometrics, The International Biometric Society, vol. 62(3), pages 670-673, September.
    6. Werner Brannath & Cyrus R. Mehta & Martin Posch, 2009. "Exact Confidence Bounds Following Adaptive Group Sequential Tests," Biometrics, The International Biometric Society, vol. 65(2), pages 539-546, June.
    7. Hartung, Joachim, 2000. "A self-designing rule for clinical trials with arbitrary response variables," Technical Reports 2000,11, Technische Universität Dortmund, Sonderforschungsbereich 475: Komplexitätsreduktion in multivariaten Datenstrukturen.
    8. 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.
    9. Chau T. Thach & Lloyd D. Fisher, 2002. "Self-Designing Two-Stage Trials to Minimize Expected Costs," Biometrics, The International Biometric Society, vol. 58(2), pages 432-438, June.
    10. Hartung, Joachim, 2000. "A new class of self-designing clinical trials," Technical Reports 2000,12, Technische Universität Dortmund, Sonderforschungsbereich 475: Komplexitätsreduktion in multivariaten Datenstrukturen.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:bla:biomet:v:57:y:2001:i:1:p:172-177. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Wiley Content Delivery (email available below). General contact details of provider: http://www.blackwellpublishing.com/journal.asp?ref=0006-341X .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.