多发性硬化症临床试验报告结果的差异:临床试验.gov和同行评审期刊之间的比较
Alejandro Rivero-de-Aguilar1,2, Mónica Pérez-Ríos3,4, Marta Mascareñas-García2,5
1Department of Neurology, University Hospital Complex of Pontevedra, Pontevedra, Spain.
概括
从ClinicalTrials.gov和杂志上的多发性硬化症 (MS) 临床试验数据进行比较,发现了差异. 虽然ClinicalTrials.gov提供更快的报告,但期刊刊物往往缺乏详细的安全信息,影响透明度.
科学领域:
- 临床研究方法论临床研究方法论
- 制药科学 制药科学 制药科学
- 神经学 神经学
背景情况:
- ClinicalTrials.gov是临床试验的注册表,而同行评审期刊则发布研究结果.
- 多发性硬化症 (MS) 是一种慢性神经疾病,影响中枢神经系统.
研究的目的:
- 为了比较ClinicalTrials.gov和同行评审出版物之间的III期和IV期多发性硬化症药物临床试验报告结果.
- 评估这两个来源之间的疗效和安全数据的一致性和完整性.
主要方法:
- 在ClinicalTrials.gov.gov上注册的65个多发性硬化症临床试验被确定.
- 在PubMed,EMBASE和谷歌学者中进行搜索,以找到匹配的出版物.
- 提取并比较参与者,疗效和安全性数据,将一致性分为"一致"",不一致"或"不可比较".
主要成果:
- 临床试验.gov报告速度更快 (中位数为16.4个月与27.3个月).
- 期刊的总体信息可用性更高,除了严重不良事件 (SAE) 和它们的描述.
- 在69.2%的试验中发现了显著的差异,在报告死亡原因和SAE描述中发现了显著的不一致.
结论:
- 咨询ClinicalTrials.gov和期刊,可以更好地获取多发性硬化症临床试验结果.
- 来源之间的差异和缺失的数据引发了人们对调查结果的透明度和通用性的担忧.
相关概念视频
Clinical Trials
8.5K
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...
8.5K
Clinical Trials: Overview
4.7K
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...
4.7K
Bioavailability Study Design: Single Versus Multiple Dose Studies
383
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
383
Bioavailability Study Design: Healthy Subjects Versus Patients
248
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,...
248
Bioequivalence studies: Biowaivers
430
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
430
Bioequivalence of Drugs: Drugs with Multiple Indications
230
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
230


