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

A. Palsgrove
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引用次数: 1

摘要

FDA的行业指南,患者报告的结果(PRO)措施:用于医疗产品开发以支持标签声明(即“PRO指南”);2009年)概述了FDA如何评估用于支持治疗学临床试验项目疗效终点的PRO测量方法的观点。之前的审查试图在产品标签中识别基于PRO的声明,以评估PRO指南对基于PRO的声明批准率的潜在影响,但在2010年之后没有颁布。深入搜索了2006年1月至2014年12月期间FDA批准的药品标签,其功效声明得到了PRO措施的支持。按化学药品类型和批准年份对药品标签进行分类,并对PRO指南定稿前后时间段的差异进行统计检验。结果显示,2009年之后,由PRO措施支持的基于标签的疗效声明的总体批准数量有所减少,这可能表明,更少的3期临床试验项目达到了将主观评估作为支持治疗疗效的主要或次要终点的机构基准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.
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