The Changing Landscape of Heart Failure Drug Clinical Trials in China, 2013-2023.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-04-03 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S511608

Wenjie Zhang, Yinming Zhang, Jiawei Tang, Xuejiao Wang, Chao Meng, Ji Wu, Jun Li

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引用次数: 0

Abstract

Objective: This review aimed to delineate the changing landscape of heart failure (HF) drug clinical trials conducted in China during 2013-2023.

Methods: Detailed information on HF drug trials registered on the National Medical Products Administration Clinical Trial Information Disclosure Platform from January 1, 2013, to December 31, 2023, was collected. The characteristics, drug mechanisms, data safety, participant protection, geographical locations, and scales of HF drug clinical trials were analyzed.

Results: China initiated 354 hF drug clinical trials during 2013-2023, encompassing eight acute heart failure (AHF) trials and 346 trials for chronic heart failure (CHF). The overall number of HF trials continued to increase, whereas the number of AHF trials remained consistently low. Significant differences were observed between AHF and CHF trials regarding trial phases, drug types, trial designs, blinding methods, and geographical coverage. 85.8% CHF trials were bioequivalence studies, whereas AHF trials were exclusively Phase I-III studies. Most trial drugs were chemical drugs, with renin-angiotensin-aldosterone system inhibitors accounting for the highest proportion. Sixteen new drug studies involved 13 different new drugs. The proportion of studies establishing independent data monitoring committees annually remained generally low, whereas the proportion of studies purchasing clinical trial insurance for participants annually exhibited an overall upward trend. The 354 trials were led by principal investigators from 27 provinces, autonomous regions, or municipalities in China. 47.2% leading units for these studies were distributed in the eastern coastal regions of China. There were 30 drug clinical trials with more than ten participating centers and 16 drug clinical trials with a target number of participants of over 1000 individuals.

Conclusion: Over the past decade, China has experienced rapid development in HF drug trials, particularly in drug consistency evaluations. All stakeholders involved in drug trials should carefully consider the inadequate innovations in first-in-class drugs.

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2013-2023年中国心力衰竭药物临床试验的变化趋势

目的：本综述旨在描述2013-2023年在中国进行的心力衰竭（HF）药物临床试验的变化情况。方法：收集2013年1月1日至2023年12月31日在国家药品监督管理局临床试验信息公开平台注册的HF药物试验的详细信息。分析了心衰药物临床试验的特点、作用机制、数据安全性、受试者保护、地理位置和规模。结果：2013-2023年间，中国启动了354项心衰药物临床试验，包括8项急性心力衰竭（AHF）试验和346项慢性心力衰竭（CHF）试验。HF试验的总数继续增加，而AHF试验的数量一直很低。AHF和CHF试验在试验阶段、药物类型、试验设计、盲法和地理覆盖方面存在显著差异。85.8%的CHF试验是生物等效性研究，而AHF试验完全是I-III期研究。试验药物以化学药物为主，其中肾素-血管紧张素-醛固酮系统抑制剂所占比例最高。16项新药研究涉及13种不同的新药。每年建立独立数据监测委员会的研究比例仍然普遍较低，而每年为参与者购买临床试验保险的研究比例总体呈上升趋势。354项试验由来自中国27个省、自治区或直辖市的主要研究者领导，47.2%的主导单位分布在中国东部沿海地区。有30项药物临床试验，参与中心超过10个；有16项药物临床试验，目标参与人数超过1000人。结论：在过去的十年中，中国在心衰药物试验方面取得了快速发展，特别是在药物一致性评价方面。参与药物试验的所有利益相关者都应仔细考虑首类药物创新不足的问题。

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

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.