{"title":"肿瘤临床发展项目中伴随诊断的决策制定","authors":"L. Kaiser, Claus Becker, S. Kukreti, B. Fine","doi":"10.1177/0092861512438748","DOIUrl":null,"url":null,"abstract":"The decision to incorporate the specific evaluation of a candidate companion diagnostic (CDx) in a clinical development plan (CDP) is often difficult and is exacerbated by the lack of relevant decision tools. In this article, we discuss a novel method to assess the probability of technical success (PTS) of a CDP that adequately evaluates a CDx compared with a CDP that doesn’t. We propose splitting the PTS into subjective (biological uncertainty) and quantitative (clinical uncertainty) components, assessing each separately, and then combining them in a decision theoretical manner to obtain an overall success probability of a CDP with and without a CDx.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"69 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program\",\"authors\":\"L. Kaiser, Claus Becker, S. Kukreti, B. Fine\",\"doi\":\"10.1177/0092861512438748\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The decision to incorporate the specific evaluation of a candidate companion diagnostic (CDx) in a clinical development plan (CDP) is often difficult and is exacerbated by the lack of relevant decision tools. In this article, we discuss a novel method to assess the probability of technical success (PTS) of a CDP that adequately evaluates a CDx compared with a CDP that doesn’t. We propose splitting the PTS into subjective (biological uncertainty) and quantitative (clinical uncertainty) components, assessing each separately, and then combining them in a decision theoretical manner to obtain an overall success probability of a CDP with and without a CDx.\",\"PeriodicalId\":391574,\"journal\":{\"name\":\"Drug information journal : DIJ / Drug Information Association\",\"volume\":\"69 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2012-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug information journal : DIJ / Drug Information Association\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/0092861512438748\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug information journal : DIJ / Drug Information Association","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/0092861512438748","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program
The decision to incorporate the specific evaluation of a candidate companion diagnostic (CDx) in a clinical development plan (CDP) is often difficult and is exacerbated by the lack of relevant decision tools. In this article, we discuss a novel method to assess the probability of technical success (PTS) of a CDP that adequately evaluates a CDx compared with a CDP that doesn’t. We propose splitting the PTS into subjective (biological uncertainty) and quantitative (clinical uncertainty) components, assessing each separately, and then combining them in a decision theoretical manner to obtain an overall success probability of a CDP with and without a CDx.
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