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Group Sequential Design for Comparative Diagnostic Accuracy Studies: Implications and Guidelines for Practitioners

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  • Madhu Mazumdar

    (Memorial Sloan-Kettering Cancer Center, 307 E. 63rd St., 3rd floor, New York, NY 10021; phone: 646-735-8115; fax: 646-735-0010mazumdar@biost.mskcc.org.)

Abstract

Purpose. Comparative diagnostic accuracy (CDA) studies are typically small retrospective studies supporting a higher accuracy for one modality over another for either staging a particular disease or assessing response to therapy, and they are used to generate hypotheses for larger prospective trials. The purpose of this article is to introduce the group sequential design (GSD) approach in planning these larger trials. Methods. Methodology needed for using GSD in the CDA studies is recently developed. In this article, GSD with the O’Brien and Fleming (OBF) stopping rule is described and guidelines for sample size calculation are provided. Simulated data is used to demonstrate the application of GSD in the design/analysis of a clinical trial in theCDAstudy setting. Results. The expected sample size needed for planning a trial with GSD (under the OBF stopping rule) is slightly inflated but may ultimately result in greater savings of patient resources. Conclusion. GSD is a specialized statistical method that is helpful in balancing the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion and should be adopted for planning CDAstudies.

Suggested Citation

  • Madhu Mazumdar, 2004. "Group Sequential Design for Comparative Diagnostic Accuracy Studies: Implications and Guidelines for Practitioners," Medical Decision Making, , vol. 24(5), pages 525-533, October.
    • Handle: RePEc:sae:medema:v:24:y:2004:i:5:p:525-533
    DOI: 10.1177/0272989X04269240
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    Cited by:

    1. Hanan Hammouri & Mohammed Ali & Marwan Alquran & Areen Alquran & Ruwa Abdel Muhsen & Belal Alomari, 2023. "Adaptive Multiple Testing Procedure for Clinical Trials with Urn Allocation," Mathematics, MDPI, vol. 11(18), pages 1-20, September.
    2. Liansheng Tang & Scott S. Emerson & Xiao-Hua Zhou, 2008. "Nonparametric and Semiparametric Group Sequential Methods for Comparing Accuracy of Diagnostic Tests," Biometrics, The International Biometric Society, vol. 64(4), pages 1137-1145, December.
    3. Alexander M. Kaizer & Joseph S. Koopmeiners, 2017. "Identifying optimal approaches to early termination in two-stage biomarker validation studies," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 66(1), pages 187-199, January.

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