Expert consensus on pharmacoeconomic evaluations alongside clinical trials (2024 edition)
中国药学会药物经济学专业委员会 吴晶 1刘国恩 2吕相征
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作者信息
1. 天津大学医学部药物科学与技术学院，天津 300072
2. 北京大学全球健康发展研究院，北京 100091
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摘要
药物经济学评价作为指导医药资源优化配置的技术工具，其证据已被逐步应用到国家基本医疗保险药品目录调整等国家医疗卫生决策中。随着药品上市、医保准入等决策进度不断加快，医疗卫生决策对药物经济学评价的需求也不断提升，在药品临床试验期间加载药物经济学评价设计，已成为重要研究方向与循证证据来源。为了提升此研究领域的规范性，本共识从中国医疗卫生体系与决策环境出发，围绕如何在临床试验中加载药物经济学评价这一主题，形成涵盖研究设计、数据收集与管理、数据分析以及方法与结果报告全流程的推荐意见。共识内容从目标人群、对照的选择、样本量的计算、医疗资源使用数据的收集、健康相关生命质量数据的收集、成本的分析、健康结果的分析、缺失和删失数据的处理等18个方面，形成24个方法学与实践操作的核心推荐意见，以期为相关领域研究者和决策者提供参考。 As a technical tool to guide the optimal allocation of healthcare resources, pharmacoeconomic evaluation has been gradually applied to national healthcare decisions, including the adjustment of the National Reimbursement Drug List in China. With the acceleration of drug market approval and access to insurance coverage, the demand for pharmacoeconomic evaluation in healthcare decision-making is also increasing. Designing a pharmacoeconomic evaluation alongside clinical trials has become an important research direction and the source of evidence. In order to facilitate the standardization of this research field, the current consensus focuses on the topic of how to conduct a pharmacoeconomic evaluation alongside clinical trials from the Chinese healthcare system and decision-making context. The consensus group reconciled expert opinions and developed recommendations covering the entire process of study design, data collection and management, data analysis, and methods and results reporting. A total of 24 recommendations regarding to methodology and practice were developed from eighteen aspects including target population, selection of comparators, calculation of sample size, data collection of healthcare resource utilization, data collection of health-related quality of life, cost analysis, health outcome analysis, addressing the missing and censored data, etc., with the aim to provide reference for scholars and decision makers in this research filed.
Abstract
As a technical tool to guide the optimal allocation of healthcare resources, pharmacoeconomic evaluation has been gradually applied to national healthcare decisions, including the adjustment of the National Reimbursement Drug List in China. With the acceleration of drug market approval and access to insurance coverage, the demand for pharmacoeconomic evaluation in healthcare decision-making is also increasing. Designing a pharmacoeconomic evaluation alongside clinical trials has become an important research direction and the source of evidence. In order to facilitate the standardization of this research field, the current consensus focuses on the topic of how to conduct a pharmacoeconomic evaluation alongside clinical trials from the Chinese healthcare system and decision-making context. The consensus group reconciled expert opinions and developed recommendations covering the entire process of study design, data collection and management, data analysis, and methods and results reporting. A total of 24 recommendations regarding to methodology and practice were developed from eighteen aspects including target population, selection of comparators, calculation of sample size, data collection of healthcare resource utilization, data collection of health-related quality of life, cost analysis, health outcome analysis, addressing the missing and censored data, etc., with the aim to provide reference for scholars and decision makers in this research filed.
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