2013-2022年中国行业资助儿科临床试验的最新情况和趋势

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-01-03 DOI:10.1002/ped4.12409

Chang Liu, Yi Liu, Ling Ou, Yuenan Qi, Jianmin Zhang

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引用次数: 0

摘要

儿科用药是一个具有挑战性的全球性问题。为了探索2013年至2022年中国制药企业开展新药临床试验的最新情况，为制药行业儿科药物开发和监管政策制定提供见解。我们对2013年1月1日至2022年12月31日期间在 "药物临床试验注册与信息公开平台 "上注册的儿科临床试验进行了横断面观察调查，该平台于2013年建立，是生物制药企业开展新药临床试验的官方注册平台。共收集到 895 项儿科临床试验，占 2023 年 1 月 1 日前启动的注册临床试验总数的 5.1%。儿科临床试验数量的总体年均增长率为12%（P < 0.001）。III期试验所占比例最高（49.1%，439项）。在纳入的895项试验中，736项（82.2%）为国内试验，159项（17.8%）为国际多中心试验。从试验药物来看，生物制品的研究占比最高（67.4%，603 项）。在儿科临床试验中，疫苗研究占的比例最大（41.0%，367 例），其次是罕见病试验（17.2%，154 例）。行业资助的儿童临床试验的增长趋势表明，自 2013 年以来，中国儿科药物研发取得了长足进步，能力不断增强。目前，政策制定者和利益相关者面临的挑战和潜在的重点领域包括：根据中国儿童独特的流行病学特征研究罕见病孤儿药，扩大儿科临床试验的范围，以及改善领先研究中心地理分布不均衡的状况。

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Recent landscape and trends for industry‐sponsored pediatric clinical trials in China from 2013 to 2022

Pediatric medication is a challenging issue globally. Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important.To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation.We performed a cross‐sectional observational investigation of pediatric clinical trials registered from January 1, 2013, to December 31, 2022, on the Registration and Information Disclosure Platform for Drug Clinical Trials, the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises. Trials that included pediatric participants (under 18 years old) were retrieved, and their relevant characteristics were extracted and analyzed.In total, 895 pediatric clinical trials were collected, accounting for 5.1% of the total registered clinical trials initiated prior to January 1, 2023. The overall average annual growth rate for the number of pediatric clinical trials was 12% (P < 0.001). Phase III trials accounted for the highest proportion (49.1%, 439). Of the 895 trials included, 736 (82.2%) were domestic trials, and 159 (17.8%) were international multicenter trials. In terms of tested drugs, investigations of biological products accounted for the largest proportion of trials (67.4%, 603). Among pediatric clinical trials, studies of vaccines accounted for the largest proportion of trials (41.0%, 367), followed by trials for rare diseases (17.2%, 154). Furthermore, geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China (35.7%, 320) and Northeast China (0.8%, 7), respectively.The growth trends for industry‐sponsored clinical trials involving children illustrate the progress and increasing capability of pediatric drug development achieved in China since 2013. Current challenges and potential areas of focus for policymakers and stakeholders include investigating orphan drugs for rare diseases according to the unique epidemiological characteristics of Chinese children, expanding the scope of pediatric clinical trials, and improving the uneven geographical distribution of leading research centers.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.