非劣等性实用试验的未解决问题:文献调查结果
Maria M Ciarleglio1, Jiaxuan Li1, Peter Peduzzi1
1Department of Biostatistics, Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT, USA.
Clinical trials (London, England)
|November 6, 2023
概括
随机的非劣势实证试验可能由于边缘,坚持和分析群体的问题而产生偏差结果. 这些试验需要新的指导方针,以防止偏见并确保可靠的结果.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 公共卫生研究 公共卫生研究
背景情况:
- 随机的非劣势实证试验面临潜在的偏差从边际,坚持和分析群体的规范.
- 调查这些问题对于试验结果的完整性至关重要.
研究的目的:
- 检查非劣等性实用试验如何解决潜在的偏见来源.
- 为了确定这些试验类型的当前方法的挑战.
主要方法:
- 从2015年到2021年,主要的医学期刊 (NEJM,JAMA,Lancet,BMJ) 进行了有针对性的文献搜索.
- 研究包括使用"务实"或"比较有效性"与"非劣势"或"非劣势"关键词的研究.
- 十二项试验符合分析的纳入标准.
主要成果:
- 十一项试验符合非劣势标准;大多数试验中预先规定的利率得到了证明.
- 在大多数试验中,对治疗的坚持得到了监测.
- 虽然治疗意图和每项方案分析得出了类似的结论,但由于各种原因,大量的参与者 (高达30%) 被排除在首要分析之外.
结论:
- 仔细考虑边缘,坚持和分析群体是防止在非劣势实证试验中偏见的关键.
- 现有的关于非劣等性和实用性试验的单独指南是不相容的.
- 建议制定新的指导方针,以有效地进行非劣势实用性试验.
关键词:
实用临床试验实用临床试验估计 估计 估计 估计非劣势利率 (non-inferiority margins) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin) 是指非劣势利率 (non-inferiority margin).不低劣性试验的试验.更多相关视频
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
8.4K
08:24The Joint Effect of Social Comparison and Social Distance on Evaluation of Intertemporal Choice Outcomes in Event-related Potential Studies
Published on: August 25, 2023
740
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
133
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,...
133
Clinical Trials
6.8K
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...
6.8K
Ethical Issues
981
Nurses are essential in patient care, upholding the ethical principles of their profession and effectively navigating ethical dilemmas. Neglecting ethical issues can lead to inadequate patient care, compromised therapeutic relationships, and moral distress among healthcare workers.
Ethical Concerns in Healthcare:
Ethical Concerns in Healthcare:
981
Bias
4.3K
Bias refers to any tendency that prevents a question from being considered unprejudiced. In research, bias occurs when one outcome or answer is selected or encouraged over others in sampling or testing. Bias can occur during any research phase, including study design, data collection, analysis, and publication.
In statistics, a sampling bias is created when a sample is collected from a population, and some members of the population are not as likely to be chosen as others (remember, each member...
In statistics, a sampling bias is created when a sample is collected from a population, and some members of the population are not as likely to be chosen as others (remember, each member...
4.3K
Blinding
2.5K
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.
2.5K
Hazard Ratio
136
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...
136
