Improving the biomarker pipeline to develop and evaluate cancer screening tests.
The biomarker pipeline to develop and evaluate cancer screening tests has three stages: identification of promising biomarkers for the early detection of cancer, initial evaluation of biomarkers for cancer screening, and definitive evaluation of biomarkers for cancer screening. Statistical and biological issues to improve this pipeline are discussed. Although various recommendations, such as identifying cases based on clinical symptoms, keeping biomarker tests simple, and adjusting for postscreening noise, have been made previously, they are not widely known. New recommendations include more frequent specimen collection to help identify promising biomarkers and the use of the paired availability design with interval cases (symptomatic cancers detected in the interval after screening) for initial evaluation of biomarkers for cancer screening.
Baker
Stuart G
SG
Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA. sb16i@nih.gov
D015982:Bias; D014408:Biomarkers, Tumor / Q000097:blood*; D002986:Clinical Trials as Topic; D055088:Early Detection of Cancer; D004866:Equipment Contamination; D006801:Humans; D008403:Mass Screening / Q000379:methods; D009363:Neoplasm Proteins / Q000097:blood*; D009369:Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000453:epidemiology; D010349:Patient Compliance; D011237:Predictive Value of Tests; D011379:Prognosis; D012372:ROC Curve
D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins