在2014年至2024年期间在ClinicalTrials.gov上注册的停止放射治疗试验的分析
Bian Wu1, Mengting Li1, Peng Ding1
1Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan 430022, China; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
概括
与其他瘤学试验相比,放射治疗试验的中止可能性较低,但由于患者入学率不佳,近60%的试验终止. 资金,地点和研究设计等因素影响放射治疗试验的完成.
科学领域:
- 在瘤学瘤学.
- 临床试验管理 临床试验管理
- 辐射瘤学 辐射瘤学
背景情况:
- 过早结束的临床试验意味着大量资源的损失,患者的负担,以及对科学进步的损害.
- 放射治疗试验中断率和具体原因在很大程度上仍未被描述.
研究的目的:
- 分析与停止放射治疗试验相关的患病率,原因和特征.
- 确定影响终止或完成放射治疗试验的预测因素.
主要方法:
- 在2014年6月1日至2024年6月1日期间在ClinicalTrials.gov注册的瘤学试验的综合分析.
- 试验被分为放射治疗和其他瘤学试验组,以比较中止率和原因.
- 采用多变量逻辑回归来确定预测放射治疗试验中止的因素.
主要成果:
- 与其他瘤学试验 (12.8%) 相比,放射治疗试验 (总数的5.1%) 的终止/戒断率 (8.6%) 较低.
- 报名不足是放弃放射治疗试验的主要原因 (58.7%),与商业/赞助商决定 (1.9%) 相反.
- 停药的预测因素包括并行组设计,国家卫生研究院 (NIH) 赞助和学术机构赞助;多地点,亚洲和欧洲的试验显示完成率更高.
结论:
- 患者积累不良是放射治疗试验失败的主要原因,占停止治疗的近60%.
- 试验结果受到资金来源,地理位置和特定研究设计的重大影响.
- 战略干预对于提高放射治疗试验完成率和支持基于证据的放射瘤学至关重要.
相关概念视频
01:16Clinical 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
01:21Cancer Survival Analysis
645
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
645
01:12Hazard Ratio
560
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...
560
01:11Clinical Trials: Overview
4.6K
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...
4.6K
01:20Comparing the Survival Analysis of Two or More Groups
553
Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and...
553
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
406
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,...
406