在类风湿性关节炎的临床试验中,全球招募模式和安慰剂反应
Andreas Kerschbaumer1, Marlene Steiner1, Pascale Pruckner1
1Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria.
Annals of the rheumatic diseases
|August 2, 2025
概括
在临床试验中从低收入国家招募类风湿性关节炎患者与更高的安慰剂反应有关. 积极治疗的疗效保持一致,强调需要在试验设计中考虑社会经济因素.
科学领域:
- 临床试验 临床试验
- 类风湿病学 类风湿病学
- 卫生经济学 卫生经济学
背景情况:
- 在类风湿性关节炎 (RA) 临床试验中,安慰剂效应带来了重大挑战.
- 了解社会经济因素对安慰剂反应的影响对于优化试验设计和结果至关重要.
研究的目的:
- 调查全球招募模式对RA随机对照试验 (RCT) 中安慰剂反应的影响.
- 评估招聘国家的社会经济指标与安慰剂反应率之间的关系.
主要方法:
- 对124项RA试验 (14,272名患者) 的分析,调查了向治疗方法.
- 使用人均国民总收入 (GNI) 作为社会经济地位的代表,与人类发展指数和自费医疗支出一起.
- 通过使用来自全球RCT的患者级数据验证的结果.
主要成果:
- 在GNI和安慰剂反应率之间发现了显著的负相关性 (β = -3.7%每1万美元增加的国际美元).
- 使用替代社会经济指标和个体患者级别的地理数据证实了这一关联.
- 国民总收入对安慰剂反应的影响与其对积极治疗反应的影响有意义地不同.
结论:
- 从低收入国家招募患者与RA试验中更高的安慰剂反应率相关.
- 积极治疗反应在不同收入水平保持稳定,这表明社会经济因素主要影响安慰剂效应.
- 解决这些社会经济驱动因素对于提高临床试验设计和确保准确的疗效评估至关重要.
相关概念视频
01:11Clinical Trials: Overview
3.4K
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...
3.4K
01:54The Placebo Effect
6.3K
The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.
6.3K
01:16Clinical Trials
8.4K
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...
8.4K
01:11Genome-wide Association Studies-GWAS
14.2K
Genome-wide association studies or GWAS are used to identify whether common SNPs are associated with certain diseases. Suppose specific SNPs are more frequently observed in individuals with a particular disease than those without the disease. In that case, those SNPs are said to be associated with the disease. Chi-square analysis is performed to check the probability of the allele likely to be associated with the disease.
GWAS does not require the identification of the target gene involved in...
GWAS does not require the identification of the target gene involved in...
14.2K
02:07Blind Procedures
12.1K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
12.1K
01:11Blinding
2.6K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
2.6K