Leveraging Real-world Evidence for Antihypertensive Fixed-dose Combinations: A Multidimensional Narrative Review From European Industry Perspective.

IF 3.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2025-08-21 DOI:10.1016/j.clinthera.2025.07.024

Mariusz Mogielnicki, Volodymyr Stus, Artur Banaszak

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引用次数: 0

Abstract

Purpose: Real-world data (RWD) and real-world evidence (RWE) offer significant potential for clinical development and clinical evidence generation. This review addresses the complexity surrounding the use of RWD and RWE in drug repurposing, such as antihypertensive fixed-dose combinations of known compounds from the 5 major pharmacological classes.

Methods: We performed a narrative review examining RWD and RWE use in the development and registration of antihypertensive fixed-dose combinations, covering their role as examples of value-added medicines, regulatory policies, scientific perceptions, application in hypertension research, regulatory use cases, and economic factors.

Findings: Well-designed RWE studies can yield clinical performance data comparable with findings of randomized controlled trials while addressing certain limitations. However, current European Union (EU) legislation regarding the usability of RWD and RWE is conservative and needs to be updated. Divergent opinions among EU member states pose uncertainty and risk for industry in marketing authorization applications involving RWD and RWE.

Implications: Real-world data and RWE offer a transformative opportunity through data sourced beyond traditional clinical trials. This approach can expedite regulatory decisions, reduce development timelines and costs, and accelerate the delivery of valuable therapies to patients. Discussions at the centralized EU regulatory level are needed to recognize and accept RWE as valid for demonstrating clinical efficacy and safety.

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利用真实世界的证据抗高血压固定剂量组合：从欧洲工业角度的多维叙事回顾。

目的：真实世界数据（RWD）和真实世界证据（RWE）为临床发展和临床证据生成提供了巨大的潜力。本综述探讨了RWD和RWE在药物再利用中的复杂性，例如5种主要药理学类别的已知化合物的抗高血压固定剂量组合。方法：我们对RWD和RWE在抗高血压固定剂量联合用药开发和注册中的应用进行了叙述性回顾，涵盖了它们作为增值药物范例的作用、监管政策、科学观念、在高血压研究中的应用、监管用例和经济因素。研究结果：设计良好的RWE研究可以得出与随机对照试验结果相当的临床表现数据，同时解决了某些局限性。然而，目前欧盟（EU）关于RWD和RWE可用性的立法是保守的，需要更新。欧盟成员国之间的意见分歧给涉及RWD和RWE的上市许可申请行业带来了不确定性和风险。启示：现实世界的数据和RWE提供了一个变革性的机会，通过数据来源超越传统的临床试验。这种方法可以加快监管决策，缩短开发时间和成本，并加速向患者提供有价值的疗法。需要在欧盟集中监管层面进行讨论，以承认和接受RWE在证明临床疗效和安全性方面是有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.