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A Modified Risk Set Approach to Biomarker Evaluation Studies

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  • Debashis Ghosh

    (Colorado School of Public Health)

Abstract

There is tremendous scientific and medical interest in the use of biomarkers to better facilitate medical decision making. In this article, we present a simple framework for assessing the predictive ability of a biomarker. The methodology requires use of techniques from a subfield of survival analysis termed semi-competing risks; results are presented to make the article self-contained. As we show in the article, one natural interpretation of semi-competing risks model is in terms of modifying the classical risk set approach to survival analysis that is more germane to medical decision making. A crucial parameter for evaluating biomarkers is the predictive hazard ratio, which is different from the usual hazard ratio from Cox regression models for right-censored data. This quantity will be defined; its estimation, inference, and adjustment for covariates will be discussed. Aspects of causal inference related to these procedures will also be described. The methodology is illustrated with an evaluation of serum albumin in terms of predicting death in patients with primary biliary cirrhosis.

Suggested Citation

  • Debashis Ghosh, 2016. "A Modified Risk Set Approach to Biomarker Evaluation Studies," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 8(2), pages 395-406, October.
    • Handle: RePEc:spr:stabio:v:8:y:2016:i:2:d:10.1007_s12561-016-9166-8
    DOI: 10.1007/s12561-016-9166-8
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    References listed on IDEAS

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    1. P. Saha & P. J. Heagerty, 2010. "Time-Dependent Predictive Accuracy in the Presence of Competing Risks," Biometrics, The International Biometric Society, vol. 66(4), pages 999-1011, December.
    2. Yingye Zheng & Tianxi Cai & Yuying Jin & Ziding Feng, 2012. "Evaluating Prognostic Accuracy of Biomarkers under Competing Risk," Biometrics, The International Biometric Society, vol. 68(2), pages 388-396, June.
    3. Patrick J. Heagerty & Yingye Zheng, 2005. "Survival Model Predictive Accuracy and ROC Curves," Biometrics, The International Biometric Society, vol. 61(1), pages 92-105, March.
    4. Debashis Ghosh, 2009. "On Assessing Surrogacy in a Single Trial Setting Using a Semicompeting Risks Paradigm," Biometrics, The International Biometric Society, vol. 65(2), pages 521-529, June.
    5. Patrick J. Heagerty & Thomas Lumley & Margaret S. Pepe, 2000. "Time-Dependent ROC Curves for Censored Survival Data and a Diagnostic Marker," Biometrics, The International Biometric Society, vol. 56(2), pages 337-344, June.
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