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Incidence of Advanced Symptomatic Disease as Primary Endpoint in Screening and Prevention Trials

¹ Department of Quantitative Health Sciences, Wb4, The Cleveland Clinic, 9500 Euclid Ave., Cleveland, OH 44195.
² Division of Radiology, The Cleveland Clinic, Cleveland, OH.
³ Department of Cardiovascular Medicine, The Cleveland Clinic, Cleveland, OH.
⁴ Department of Hematology/Medical Oncology, The Cleveland Clinic, Cleveland, OH.

Abstract

OBJECTIVE. Randomized clinical trials (RCTs) using disease-specific mortality as the primary outcome are the gold standard for evaluating the efficacy of screening tests. These trials require thousands of subjects and 8–10 years of follow-up; often the imaging technology has changed by the end of the trial.

CONCLUSION. We propose the incidence of symptomatic disease as an alternative to disease-specific mortality. This endpoint is sensitive to the benefit of screening, correlates with patients' quality of life and societal costs, and can dramatically reduce the sample size and follow-up requirements of RCTs.

Keywords: advanced symptomatic disease • disease-specific mortality • randomized clinical trials • screening

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