干预性临床试验在全球范围内每百万人口,每个国家均注册
Jonas Leth Bjerg1, Dimitrinka Nikolova2,3, Christian Gluud2,3,4
1Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. Jonas.bjerg@ctu.dk.
Trials
|November 26, 2025
概括
自1999年以来,全球临床试验注册数量一直在增长,较小的西方国家在人均注册数量方面处于领先地位. 需要继续努力,以促进全球临床试验注册和产出.
科学领域:
- 临床研究 临床研究
- 全球健康 全球健康
- 生物医学科学 生物医学科学
背景情况:
- 临床试验注册对于评估研究活动至关重要,它补充了出版数据.
- 世界卫生组织的国际临床试验注册平台 (ICTRP) 提供了自1999年以来的全球数据.
- 强制执行的注册政策增强了全球和国家临床研究评估.
研究的目的:
- 为量化在2009-2022年期间全球每百万人口注册的干预性临床试验.
- 为了比较在国际上增加采用注册要求的时期的注册活动,与整个1999-2022年时间框架相比.
主要方法:
- 利用世卫组织ICTRP数据进行年度干预临床试验注册.
- 分析了两个时期:2009-2022年 (更完整的注册) 和1999-2022年 (更广泛的范围).
- 使用世界银行和其他来源的人口统计数据计算每百万人口的登记活动.
主要成果:
- 分析了229个国家/地区的910,804项试验 (不包括未知来源).
- 排名第一的国家 (2009-2022,每百万人口):丹麦,爱沙尼亚,比利时,荷兰,新西兰.
- 排名第一的国家 (1999-2022,每百万人口):丹麦,爱沙尼亚,比利时,荷兰,拉脱维亚.
结论:
- 自1999年以来,在全球范围内观察到干预性临床试验注册的增长.
- 全球平均值:每百万人口约有97个注册试验 (2009-2022年).
- 较小的西方国家在人均临床试验注册方面表现出领先地位,这表明需要更广泛的全球参与.
相关概念视频
Clinical Trials
10.1K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.1K
Clinical Trials: Overview
4.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
387
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
387
Hazard Ratio
551
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
551
Study Designs in Epidemiology
860
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
860
Pharmacovigilance
1.6K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.6K


