{"title":"Fast-tracking drug development with biomarkers and companion diagnostics","authors":"Noreen McBrearty, Devika Bahal, S. Platero","doi":"10.20517/2394-4722.2023.134","DOIUrl":null,"url":null,"abstract":"To fully implement precision medicine, a deeper understanding of biomarkers, companion diagnostics, and their use in clinical trials is needed. Here, we describe key events in biomarker discovery and clinical trial design, and how those stages may be streamlined to fast-track approval of companion diagnostics (CDx). We discuss crucial qualities of a successful CDx that include understanding the prevalence of the marker in the intention to treat population, careful consideration of the scoring scheme that will be used in later clinical trial stages, and reliability of the performance of the CDx, in addition to other necessary features.","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":"101 45","pages":""},"PeriodicalIF":17.7000,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.20517/2394-4722.2023.134","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
引用次数: 0
Abstract
To fully implement precision medicine, a deeper understanding of biomarkers, companion diagnostics, and their use in clinical trials is needed. Here, we describe key events in biomarker discovery and clinical trial design, and how those stages may be streamlined to fast-track approval of companion diagnostics (CDx). We discuss crucial qualities of a successful CDx that include understanding the prevalence of the marker in the intention to treat population, careful consideration of the scoring scheme that will be used in later clinical trial stages, and reliability of the performance of the CDx, in addition to other necessary features.
期刊介绍：
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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