生物標誌物做什麼?
生物標記物可以執行不同的功能:
•疾病診斷-使診斷更可靠,更快和/或更便宜。
•嚴重度評估-識別患有嚴重疾病的患者。
•風險評估-識別接受干預後結果可能更好或更糟的患者。
•藥物作用的預測-識別暴露於藥物的患者的藥理反應(功效,毒性和藥代動力學)。
•監測-評估對治療干預的反應。
參考文獻
Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 2001, 69, 89–95.
Gosho, M., Nagashima, K. & Sato, Y., 2012. Study Designs and statistical analyses for biomarker research. Sensors (Switzerland), 12(7), pp.8966–8986.
Ray, P. et al., 2010. Statistical evaluation of a biomarker. Anesthesiology, 112(4), pp.1023–1040.
Strimbu, K. & Tavel, J. a, 2011. What are Biomarkers? Curr Opin HIV AIDS, 5(6), pp.463–466.
Sargent, D.J.; Conley, B.A.; Allegra, C.; Collette, L Clinical trial designs for predictive marker validation in cancer treatment trials. J. Clin. Oncol. 2005, 23, 2020–2027.
Chakravarty, A.G.; Rothmann, M.; Sridhara, R. Regulatory issues in use of biomarkers in oncology trials. Stat. Biopharm. Res. 2011, 3, 569–576.
Jenkins, M.; Flynn, A.; Smart, T.; Harbron, C.; Sabin, T.; Ratnayake, J.; Delmar, P.; Herath, A.; Jarvis, P.; Matcham, J.; On behalf of the PSI Biomarker Special Interest Group. A statistician’s perspective on biomarkers in drug development. Pharm. Stat. 2011, 6, 494–507.
Dunstan, R.W. et al., 2011. The use of immunohistochemistry for biomarker assessment–can it compete with other technologies? Toxicologic pathology, 39(6), pp.988–1002.