多基因风险评分在药物开发方案中的应用。

IF 1.9 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Michelle A Pressly, Robert Schuck, Padmaja Mummaneni, Youssef M Roman, Michael Pacanowski
{"title":"多基因风险评分在药物开发方案中的应用。","authors":"Michelle A Pressly, Robert Schuck, Padmaja Mummaneni, Youssef M Roman, Michael Pacanowski","doi":"10.1080/14622416.2025.2489916","DOIUrl":null,"url":null,"abstract":"<p><p>The development of polygenic risk scores (PRSs), which make use of genetic testing to assess an individual's risk of developing certain diseases or conditions based on collective genetic variant information, can be applied in drug development to enrich clinical trials or predict response to treatment. From querying documents submitted to the Food & Drug Administration, the landscape of use of PRSs across time shows increased use in guiding clinical trials. Of the clinical trial protocols submitted, most were in the therapeutic areas of neurology, radiology (imaging and diagnostic pharmaceuticals), psychiatry, and oncology. Use of PRSs in clinical trials is most frequent in early drug development (phase 1, phase 1/2, or phase 3) and generally supports secondary or exploratory analyses. Additionally, about half of the protocols developed novel PRSs, and the other half used preexisting PRSs. As researchers, regulators, and clinicians aim to understand the results and implications of PRSs in clinical trials, the continued use of PRSs, despite being less common, reinforces the need for further exploration.</p>","PeriodicalId":20018,"journal":{"name":"Pharmacogenomics","volume":" ","pages":"1-5"},"PeriodicalIF":1.9000,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Utilization of polygenic risk scores in drug development protocols.\",\"authors\":\"Michelle A Pressly, Robert Schuck, Padmaja Mummaneni, Youssef M Roman, Michael Pacanowski\",\"doi\":\"10.1080/14622416.2025.2489916\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The development of polygenic risk scores (PRSs), which make use of genetic testing to assess an individual's risk of developing certain diseases or conditions based on collective genetic variant information, can be applied in drug development to enrich clinical trials or predict response to treatment. From querying documents submitted to the Food & Drug Administration, the landscape of use of PRSs across time shows increased use in guiding clinical trials. Of the clinical trial protocols submitted, most were in the therapeutic areas of neurology, radiology (imaging and diagnostic pharmaceuticals), psychiatry, and oncology. Use of PRSs in clinical trials is most frequent in early drug development (phase 1, phase 1/2, or phase 3) and generally supports secondary or exploratory analyses. Additionally, about half of the protocols developed novel PRSs, and the other half used preexisting PRSs. As researchers, regulators, and clinicians aim to understand the results and implications of PRSs in clinical trials, the continued use of PRSs, despite being less common, reinforces the need for further exploration.</p>\",\"PeriodicalId\":20018,\"journal\":{\"name\":\"Pharmacogenomics\",\"volume\":\" \",\"pages\":\"1-5\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-04-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacogenomics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14622416.2025.2489916\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacogenomics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14622416.2025.2489916","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

多基因风险评分(PRSs)的开发利用基因检测来评估个人根据集体遗传变异信息罹患某些疾病或病症的风险,可应用于药物开发,以丰富临床试验或预测对治疗的反应。从查询提交给食品和药物管理局的文件来看,PRSs的使用情况随着时间的推移而增加,用于指导临床试验。在提交的临床试验方案中,大多数是在神经病学、放射学(成像和诊断药物)、精神病学和肿瘤学的治疗领域。在临床试验中使用prs最常用于早期药物开发(1期、1/2期或3期),通常支持二次或探索性分析。此外,大约一半的协议开发了新的prs,而另一半使用了已有的prs。由于研究人员、监管机构和临床医生的目标是了解prs在临床试验中的结果和影响,尽管prs不太常见,但仍在继续使用,这加强了进一步探索的必要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Utilization of polygenic risk scores in drug development protocols.

The development of polygenic risk scores (PRSs), which make use of genetic testing to assess an individual's risk of developing certain diseases or conditions based on collective genetic variant information, can be applied in drug development to enrich clinical trials or predict response to treatment. From querying documents submitted to the Food & Drug Administration, the landscape of use of PRSs across time shows increased use in guiding clinical trials. Of the clinical trial protocols submitted, most were in the therapeutic areas of neurology, radiology (imaging and diagnostic pharmaceuticals), psychiatry, and oncology. Use of PRSs in clinical trials is most frequent in early drug development (phase 1, phase 1/2, or phase 3) and generally supports secondary or exploratory analyses. Additionally, about half of the protocols developed novel PRSs, and the other half used preexisting PRSs. As researchers, regulators, and clinicians aim to understand the results and implications of PRSs in clinical trials, the continued use of PRSs, despite being less common, reinforces the need for further exploration.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Pharmacogenomics
Pharmacogenomics 医学-药学
CiteScore
3.40
自引率
9.50%
发文量
88
审稿时长
4-8 weeks
期刊介绍: Pharmacogenomics (ISSN 1462-2416) is a peer-reviewed journal presenting reviews and reports by the researchers and decision-makers closely involved in this rapidly developing area. Key objectives are to provide the community with an essential resource for keeping abreast of the latest developments in all areas of this exciting field. Pharmacogenomics is the leading source of commentary and analysis, bringing you the highest quality expert analyses from corporate and academic opinion leaders in the field.
×
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