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Cancer Screening Markers: A Simple Strategy to Substantially Reduce the Sample Size for Validation

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  • Stuart G. Baker

Abstract

Background . Studies to validate a cancer prediction model based on cancer screening markers collected in stored specimens from asymptomatic persons typically require large specimen collection sample sizes. A standard sample size calculation targets a true-positive rate (TPR) of 0.8 with a 2.5% lower bound of 0.7 at a false-positive rate (FPR) of 0.01 with a 5% upper bound of 0.03. If the probability of developing cancer during the study is P = 0.01, the specimen collection sample size based on the standard calculation is 7600. Methods . The strategy to reduce the specimen collection sample size is to decrease both the lower bound of TPR and the upper bound of FPR while keeping a positive lower bound on the anticipated clinical utility. Results . The new sample size calculation targets a TPR of 0.4 with a 2.5% lower bound of 0.10 and an FPR of 0.0 with a 5% upper bound of 0.005. With P = 0.01, the specimen collection sample size based on the new calculation is 1800 instead of 7600. Limitations . The new sample size calculation requires a minimum benefit/cost ratio (number of false positives traded for a true positive). With P = 0.01, the minimum cost-benefit ratio is 5, which is plausible in many studies. Conclusion . In validation studies for cancer screening markers, the strategy can substantially reduce the specimen collection sample size, substantially reducing costs and making some otherwise infeasible studies now feasible.

Suggested Citation

  • Stuart G. Baker, 2019. "Cancer Screening Markers: A Simple Strategy to Substantially Reduce the Sample Size for Validation," Medical Decision Making, , vol. 39(2), pages 130-136, February.
    • Handle: RePEc:sae:medema:v:39:y:2019:i:2:p:130-136
    DOI: 10.1177/0272989X18819792
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    1. Baker, Stuart G. & Kramer, Barnett S., 2007. "Peirce, Youden, and Receiver Operating Characteristic Curves," The American Statistician, American Statistical Association, vol. 61, pages 343-346, November.
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