Statistical applications for in vitro diagnostic tests and other medical device clinical trials*

摘要

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 forkbykordered 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.