Recommendations on health-related quality of life research to support labeling and promotional claims in the United States
Recommendations on health-related quality of life research to support labeling and promotional claims in the United States
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DOI：
10.1023/a:1008996223999
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发表时间：
2000-01-01
影响因子：
3.5
通讯作者：
Rothman, M
中科院分区：
文献类型：
--
作者：
Revicki, DA;Osoba, D;Rothman, M
健康相关生活质量（HRQL）结局评价正在成为新药和医疗器械临床试验的重要组成部分。HRQL研究为患者，提供者和决策者提供有关疾病和治疗对身体，心理和社会功能和福祉的影响的重要信息。这些结果对制药和器械行业也很有用，因为他们试图了解产品价值并将其传达给医生，患者，健康保险公司和其他人。未来几年，美国的HRQL标签和促销声明可能会增加。提出此类声明的证据要求应基于公认的HRQL评价科学标准，并与临床疗效的监管要求一致。本报告概述了在评估HRQL声明的证据时应考虑的科学实践，包括选择适当的领域，支持HRQL测量的可靠性和有效性的证据，研究设计和统计分析的考虑因素以及临床意义问题。来自制药和器械行业、监管机构和HRQL科学界的代表应共同努力，确保在标签和促销中使用HRQL是基于可靠的科学证据，并且这些信息明确准确地报告给消费者。
Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers.