Statistical applications for in vitro diagnostic tests and other medical device clinical trials.
Some statistical methods applied to in vitro diagnostic tests for the three primary indications (screening, diagnosis, and monitoring) are discussed. Various examples with practical statistical applications are presented, including test for k by k ordered categorical matched-pair data for screening of cervical cancer, receiver operating characteristic (ROC) curve for diagnosis or screening, and the Cox time-to-event model to estimate relative risk of first cancer progression by monitoring carcinoembryonic (CEA) levels for stage IV breast cancer patients.
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Food and Drug Administration, Rockville, Maryland 20850, USA.
D001786:Blood Glucose / Q000032:analysis; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis; D002272:Carcinoembryonic Antigen / Q000097:blood; D002986:Clinical Trials as Topic / Q000379:methods*; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis; D019937:Diagnostic Techniques and Procedures; D005260:Female; D006801:Humans; D008297:Male; D008432:Mathematical Computing; D016016:Proportional Hazards Models; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000097:blood / Q000175:diagnosis; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis; D012372:ROC Curve; D012307:Risk Factors; D013223:Statistics as Topic / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology; D014626:Vaginal Smears
D001786:Blood Glucose; D002272:Carcinoembryonic Antigen; D017430:Prostate-Specific Antigen