神经精神病学术语的趋势 在多发性硬化症注册临床试验中使用:回顾性描述性分析
Braxton Phillips1, Harasees Singh1, Maya Morcos2
1Cumming School of Medicine, University of Calgary, Calgary, AB T2N 2T8, Canada.
Healthcare (Basel, Switzerland)
|October 29, 2025
概括
在多发性硬化症 (MS) 临床试验中,对神经精神病 (NP) 疾病如疲劳和抑郁症的兴趣随着时间的推移而增长. 然而,行业资助的试验不太可能包括这些重要的NP考虑因素.
科学领域:
- 神经学 神经学
- 临床试验 研究 研究 临床试验 临床试验
- 精神病学是一个精神病学.
背景情况:
- 多发性硬化症 (MS) 患者经常经历神经精神疾病 (NP),影响生活质量.
- 临床试验对于在患有多发性硬化症 (pwMS) 的人群中开发这些NP条件的有效管理策略至关重要.
研究的目的:
- 分析在MS临床试验中纳入NP术语的时间趋势.
- 确定有关国家级的NP并发症的潜在研究缺口.
主要方法:
- 一个基于Python的程序分析了在clinicaltrials.gov (2000-2024) 上注册的MS临床试验中的NP术语 (疲劳,抑郁,疼痛,焦虑).
- 通过将NP术语的提及与试验开始年的相关性来评估时间趋势.
- 多变量逻辑回归检查了试验因子和NP术语包含之间的关联.
主要成果:
- 在2674项试验中,15.3%包括至少一个NP术语:疲劳 (293),抑郁 (115),疼痛 (98),焦虑 (49).
- 随着时间的推移,包括疲劳,抑郁和焦虑等术语的数量增加了.
- 每年试验开始的增加与NP期纳入率的6%上升有关;行业融资使这些几率下降了72%.
结论:
- 在MS临床试验中,纳入NP并发症考虑的趋势越来越大.
- 行业资助的试验显示,纳入NP考虑因素的可能性较低,这表明研究设计和资金分配存在潜在差距.
相关概念视频
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
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
Therapeutic Drug Monitoring: Overview and Classification
304
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
304
Therapeutic Drug Monitoring: Affecting Factors
196
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
196


