Biomarker Development, Methodological Challenges

Gary Cutter
{"title":"Biomarker Development, Methodological Challenges","authors":"Gary Cutter","doi":"10.17161/rrnmf.v4i3.18973","DOIUrl":null,"url":null,"abstract":"Biomarker development is a common endeavor in medical research.  The purpose is to find indicators of disease occurrence or prognostic markers for response.   The process of development of biomarkers often starts with showing mean differences between responders and non-responders  or those with a disease or condition versus those without.  However, these statistically significant mean differences, while necessary are not sufficient to validate a biomarker.  Sensitivity, specificity, positive and negative predictive value are at least as important and the relative increase in performance using the biomarker over the usual clinical variables should be demonstrated.  This paper discusses the various assessments in the context of use for the biomarker,  the need for characteristics in addition to mean differences and the importance of independent validation of putative biomarkers.  Lastly, it is hoped that the process and thoroughness be considered with recognition that the task is at best a difficult task.","PeriodicalId":309700,"journal":{"name":"RRNMF Neuromuscular Journal","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"RRNMF Neuromuscular Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17161/rrnmf.v4i3.18973","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Biomarker development is a common endeavor in medical research.  The purpose is to find indicators of disease occurrence or prognostic markers for response.   The process of development of biomarkers often starts with showing mean differences between responders and non-responders  or those with a disease or condition versus those without.  However, these statistically significant mean differences, while necessary are not sufficient to validate a biomarker.  Sensitivity, specificity, positive and negative predictive value are at least as important and the relative increase in performance using the biomarker over the usual clinical variables should be demonstrated.  This paper discusses the various assessments in the context of use for the biomarker,  the need for characteristics in addition to mean differences and the importance of independent validation of putative biomarkers.  Lastly, it is hoped that the process and thoroughness be considered with recognition that the task is at best a difficult task.
生物标志物开发,方法论挑战
生物标志物的开发是医学研究的共同课题。目的是寻找疾病发生的指标或反应的预后标志物。生物标志物的开发过程通常始于显示应答者和无应答者之间的平均差异,或者患有某种疾病或状况的人与没有这种疾病或状况的人之间的平均差异。然而,这些具有统计学意义的平均差异虽然是必要的,但不足以验证生物标志物。敏感性,特异性,阳性和阴性预测值至少同样重要,并且应该证明使用生物标志物比通常的临床变量在性能上的相对提高。本文讨论了生物标记物使用背景下的各种评估,除了平均差异之外,还需要特征,以及对假定生物标记物进行独立验证的重要性。最后,希望在审议这一进程和彻底性时认识到,这项任务充其量是一项艰巨的任务。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信