Division of Public Health Sciences, Biostatistics Program, Fred Hutchinson Cancer Research Center, Seattle Washington.
Cancer Epidemiol Biomarkers Prev. 2020 Dec;29(12):2575-2582. doi: 10.1158/1055-9965.EPI-20-0240. Epub 2020 Nov 10.
The cancer early-detection biomarker field was, compared with the therapeutic arena, in its infancy when the Early Detection Research Network (EDRN) was initiated in 2000. The EDRN has played a crucial role in changing the culture and the ways people conduct biomarker studies. The EDRN proposed biomarker developmental guidelines and biomarker pivotal trial study design standards, created biomarker reference sets and functioned as an unbiased broker for the field, implemented the most rigorous blinding policy in the biomarker field, developed an array of statistical and computational tools for early-detection biomarker evaluations, and developed a multidisciplinary team-science approach. We reviewed these contributions made by the EDRN and their impacts on maturing the field. Future challenges and opportunities in cancer early-detection biomarker translational research are discussed, particularly in strengthening biomarker discovery pipeline and conducting more efficient biomarker validation studies.
与治疗领域相比，癌症早期检测生物标志物领域在 2000 年启动早期检测研究网络（EDRN）时还处于起步阶段。EDRN 在改变人们进行生物标志物研究的方式和文化方面发挥了关键作用。EDRN 提出了生物标志物开发指南和生物标志物关键试验设计标准，创建了生物标志物参考集，并作为该领域的公正中间人，在生物标志物领域实施了最严格的盲法政策，开发了一系列用于早期检测生物标志物评估的统计和计算工具，并采用了多学科团队科学方法。我们回顾了 EDRN 所做的这些贡献及其对该领域成熟的影响。讨论了癌症早期检测生物标志物转化研究未来的挑战和机遇，特别是在加强生物标志物发现管道和进行更有效的生物标志物验证研究方面。
