利益相关者对多中心随机对照试验的主要研究人员的责任的看法
Steven Joffe1, Elizabeth F Bair1, Katharine A Gleason1
1Department of Medical Ethics & Health Policy, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Clinical trials (London, England)
|February 24, 2026
概括
利益相关者在临床试验设计和报告方面最重视学术主要研究人员. 他们的重要性在公共资助的试验中被认为比行业资助的试验更重要,一些行业和FDA团体认为他们的作用不那么重要.
科学领域:
- 临床试验的管理管理.
- 医疗服务研究 医疗服务研究
- 监管科学是一种监管科学.
背景情况:
- 学术主要研究人员 (PI) 被广泛认为对临床试验的成功至关重要.
- 关于不同利益相关者如何看待PI的领导作用的证据很少.
- 基于试验资金来源,人们对PI的作用的看法可能会有所不同.
研究的目的:
- 评估临床试验领导学术PI的利益相关者重要性评级.
- 根据试验资金 (公众与行业) 来检查这些观念的差异.
- 将PI的规范观点与更广泛的利益相关方观点进行比较.
主要方法:
- 与七个利益相关方团体进行的平行Delphi小组调查.
- 调查评估了学术PI在试验设计,进行和报告中的重要性.
- 国际PI调查 (N=92) 关于他们对学术PI领导力的规范观点.
主要成果:
- 利益相关者认为,在试验设计和传播阶段,学术PI参与是最关键的.
- 在公共资助的试验中,学术PI的重要性通常被评为高于行业资助的试验.
- 行业代表和FDA官员认为,学术PI的参与不那么重要,特别是在行业资助的试验中.
结论:
- 大多数利益相关者认为学术PI非常重要,但看法因利益相关者群体,任务和资金来源而异.
- 研究人员自己认为学术领导力对公开资助的试验比行业资助的试验更为重要.
- 调查结果强调需要将现实世界的临床试验领导实践与利益相关方规范保持一致.
相关概念视频
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
500
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,...
500
01:11Clinical Trials: Overview
5.1K
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...
5.1K
01:16Clinical Trials
10.9K
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...
10.9K
01:11Blinding
4.0K
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.
4.0K
01:56Ethics in Research
25.9K
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
25.9K
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
190
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
190