中国和美国基于真实世界证据的药品审查和批准政策:比较研究》。

IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Clinical therapeutics Pub Date : 2024-12-01 Epub Date: 2024-10-05 DOI:10.1016/j.clinthera.2024.09.009
Munire Mohetaer, Adili Tuersun, Pei Li, Su Wang, Xingyan Zhang, Yuwen Chen
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引用次数: 0

摘要

目的:在监管审查和批准中使用真实世界证据(RWE)目前正经历着重大变化,讨论日益活跃,主要体现在相关政策、法规和指导文件中。然而,中美两国在接受和制定将真实世界数据/证据(RWD/E)纳入监管评估和审批的政策方面仍存在差距。此外,现行政策缺乏有效实施和广泛采用所需的具体操作细节:方法:在对相关政策、法规和指南以及其官方网站上公布的相关信息进行系统的文献综述和比较后,我们分析了基于真实世界数据/证据的药品审评和审批政策的关键方面,以突出中美两国在这些政策方面的异同:本文回顾了中美两国的框架和现有指南,讨论了在相关定义、数据来源、数据标准、数据质量和连通性、信息要求、研究设计、人员培训和沟通等关键政策方面的异同,并举例说明了RWE在药品审评审批过程中的应用:进一步制定和完善 RWE 政策,鼓励合作,分享最佳实践和成功范例,以提高政策实施的有效性和社会接受度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug Review and Approval Policies Based on Real-world Evidence in China and the United States: A Comparative Study.

Purpose: The use of real-world evidence (RWE) in regulatory reviews and approvals is currently experiencing significant changes amid increasingly active discussions, primarily reflected in relevant policies, regulations, and guidance documents. However, disparities persist between China and the United States regarding the acceptance and formulation of policies for incorporating real-world data/evidence (RWD/E) in regulatory evaluation and authorization. Furthermore, the current policies lack specific operational details necessary for effective implementation and widespread adoption.

Methods: After conducting a systematic literature review and comparing relevant policies, regulations, and guidelines, as well as the related information published on their official websites, we analyze key aspects of RWE-based drug review and approval policies to highlight similarities and differences in these policies between China and the United States.

Findings: This paper reviews the frameworks and existing guidelines in China and the U.S., discussing similarities and differences observed in key policy aspects, including relevant definitions, data sources, data standards, data quality, and connectivity, information requirements, study design, personnel training, and communication, including an example of the application of RWE in drug review and approval processes.

Implications: Further develop and refine RWE policies, encourage cooperation, and share best practices and successful examples to enhance the effectiveness of policy implementation and increase its social acceptance.

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来源期刊
Clinical therapeutics
Clinical therapeutics 医学-药学
CiteScore
6.00
自引率
3.10%
发文量
154
审稿时长
9 weeks
期刊介绍: Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.
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