{"title":"评估2006-2014年FDA关于基于临床试验的批准药品标签声明的患者报告结果(PROs)措施指南的影响","authors":"A. Palsgrove","doi":"10.3109/10601333.2015.1064441","DOIUrl":null,"url":null,"abstract":"Abstract The FDA’s Guidance for Industry, Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (i.e. “PRO Guidance”; 2009) outlines the agency’s perspectives on how PRO measures, used to support efficacy end-points in therapeutics clinical trial programs, may be evaluated by the FDA. Prior reviews have attempted to identify PRO-based statements in product labels in order to evaluate the potential impacts of the PRO guidance on the rate of approvals of PRO-based claims, but none have been enacted after 2010. An in-depth search identified drug product labels approved by the FDA from January 2006 through to December 2014, with efficacy statements supported by PRO measures. Drug product labels were sorted by chemical type and year of approval, and the differences between time periods before and after the finalization of the PRO Guidance were reviewed with statistical tests. Results showed a reduction in the overall approvals of label-based efficacy statements supported by PRO measures after 2009, which may indicate that fewer phase 3 clinical trial programs have met agency benchmarks for the inclusion of subjective assessments as primary or secondary end-points in support of therapeutic efficacy.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2015-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Evaluating the impacts of the FDA’s guidance for patient-reported outcomes (PROs) measures on clinical trial-based approved drug product labeling claims, 2006–2014\",\"authors\":\"A. Palsgrove\",\"doi\":\"10.3109/10601333.2015.1064441\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract The FDA’s Guidance for Industry, Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (i.e. “PRO Guidance”; 2009) outlines the agency’s perspectives on how PRO measures, used to support efficacy end-points in therapeutics clinical trial programs, may be evaluated by the FDA. Prior reviews have attempted to identify PRO-based statements in product labels in order to evaluate the potential impacts of the PRO guidance on the rate of approvals of PRO-based claims, but none have been enacted after 2010. An in-depth search identified drug product labels approved by the FDA from January 2006 through to December 2014, with efficacy statements supported by PRO measures. Drug product labels were sorted by chemical type and year of approval, and the differences between time periods before and after the finalization of the PRO Guidance were reviewed with statistical tests. Results showed a reduction in the overall approvals of label-based efficacy statements supported by PRO measures after 2009, which may indicate that fewer phase 3 clinical trial programs have met agency benchmarks for the inclusion of subjective assessments as primary or secondary end-points in support of therapeutic efficacy.\",\"PeriodicalId\":10446,\"journal\":{\"name\":\"Clinical Research and Regulatory Affairs\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2015-07-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research and Regulatory Affairs\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3109/10601333.2015.1064441\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2015.1064441","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Evaluating the impacts of the FDA’s guidance for patient-reported outcomes (PROs) measures on clinical trial-based approved drug product labeling claims, 2006–2014
Abstract The FDA’s Guidance for Industry, Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (i.e. “PRO Guidance”; 2009) outlines the agency’s perspectives on how PRO measures, used to support efficacy end-points in therapeutics clinical trial programs, may be evaluated by the FDA. Prior reviews have attempted to identify PRO-based statements in product labels in order to evaluate the potential impacts of the PRO guidance on the rate of approvals of PRO-based claims, but none have been enacted after 2010. An in-depth search identified drug product labels approved by the FDA from January 2006 through to December 2014, with efficacy statements supported by PRO measures. Drug product labels were sorted by chemical type and year of approval, and the differences between time periods before and after the finalization of the PRO Guidance were reviewed with statistical tests. Results showed a reduction in the overall approvals of label-based efficacy statements supported by PRO measures after 2009, which may indicate that fewer phase 3 clinical trial programs have met agency benchmarks for the inclusion of subjective assessments as primary or secondary end-points in support of therapeutic efficacy.