Baker Stuart G
Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
J Natl Cancer Inst. 2009 Aug 19;101(16):1116-9. doi: 10.1093/jnci/djp186. Epub 2009 Jul 2.
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.
识别用于癌症早期检测的有前景的生物标志物、对癌症筛查生物标志物进行初步评估以及对癌症筛查生物标志物进行最终评估。本文讨论了改进该流程的统计学和生物学问题。尽管之前已经提出了各种建议,例如根据临床症状识别病例、保持生物标志物测试简单以及调整筛查后噪声,但这些建议并未广为人知。新的建议包括更频繁地采集样本以帮助识别有前景的生物标志物,以及使用配对可用性设计结合间期病例(在筛查后的间期检测到的有症状癌症)对癌症筛查生物标志物进行初步评估。