登记临床试验 登记临床试验
Kay Dickersin1, Drummond Rennie
1Center for Clinical Trials and Evidence-based Healthcare, Brown Medical School, Providence, RI 02912, USA. kay_dickersin@brown.edu
JAMA
|July 24, 2003
概括
确保所有临床试验的注册对于防止出版偏见和保持患者信任至关重要. 综合性试验注册有利于患者,医生和研究人员,通过改善数据可访问性和推进医学知识.
科学领域:
- 医学研究伦理学医学研究伦理学
- 临床试验管理 临床试验管理
- 科学出版物 科学出版物
背景情况:
- 关于已开始的临床试验的不完整信息是全球关注的问题.
- 发表偏见,即积极结果比负面结果更受青,扭曲了医学证据.
- 缺乏全面的试验注册会削弱患者,研究人员和伦理委员会之间的信任.
研究的目的:
- 突出全面临床试验注册的关键需求.
- 解决未披露的试验数据的伦理影响,特别是在行业赞助的研究中.
- 倡导所有利益相关方立即采取协作行动,确保试验的普遍注册.
主要方法:
- 这项研究是一个概念分析和道德论证.
- 它审查了不完整的临床试验注册的后果.
- 它探讨了出版偏见的作用及其对医学知识的影响.
主要成果:
- 未能注册所有临床试验导致对医学研究的偏见.
- 未披露的负面或不确的结果代表了严重的伦理违规行为.
- 缺乏透明度尤其影响到涉及财务利益的行业赞助的试验.
结论:
- 全面的临床试验注册对于科学完整性和公众信任至关重要.
- 所有利益相关者,包括研究人员,机构,编辑和决策者,都必须优先考虑对临床试验的普遍注册.
- 对所有试验实施唯一标识符将改善数据的可访问性,打击出版偏见,加速医学进步.
相关概念视频
Data Collection by Experiments
Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public clinical trial...
An example of the experimental method is a public clinical trial...
Clinical Trials
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...
Crossover Experiments
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Blinding
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.
Clinical Trials: Overview
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...
Bioavailability Study Design: Healthy Subjects Versus Patients
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,...


