临床试验数据使用请求提案与相应出版物之间的一致性:一个横截面研究
Enrique Vazquez1, Joseph S Ross2,3,4, Cary P Gross2,5,6
1Yale University, New Haven, CT, USA.
Clinical trials (London, England)
|May 21, 2025
概括
临床试验数据共享提案经常与其公布的结果不匹配. 研究人员应该详细说明偏差,平台应该改进报告,以提高数据再利用的透明度.
科学领域:
- 临床研究是临床研究.
- 数据科学是数据科学.
- 生物统计学 生物统计学
背景情况:
- 临床试验数据共享的数量有所增加,平台要求提供数据访问建议.
- 评估提案与出版物之间的一致性对于数据完整性至关重要.
研究的目的:
- 在四个主要的数据共享平台上评估临床试验数据使用请求提案及其相应出版物的一致性.
- 确定所要求的试验,研究目标,终点和统计方法中的差异.
主要方法:
- 分析了来自Vivli,ClinicalStudyDataRequest.com,耶鲁开放数据访问项目和支持开放访问的研究人员-布里斯托尔·迈尔斯·斯奎布 (截至2023年3月) 的出版-请求对.
- 对试验,目标和统计方法的分类一致性是完全一致,部分一致,不一致或不清楚.
- 由于数据报告的变化,对耶鲁开放数据访问项目进行了终点一致性评估.
主要成果:
- 在不同平台和特征上,一致性差异很大.
- 对于Vivli来说,29.9%的对在报告的特征中完全一致;对于ClinicalStudyDataRequest.com来说,18.9%;对于Yale来说,23.1%;对于布里斯托尔·迈尔斯·斯奎布,33.3%.
- 总体而言,只有大约25%的提案在关键报告元素中完全匹配出版物.
结论:
- 临床试验数据共享提案与已公布的结果之间存在显著的不一致.
- 调查人员应在出版物中透明地报告与建议的偏差.
- 数据共享平台可以改善报告标准,以提高数据重复使用的清晰度和可靠性.
相关概念视频
01:12Hazard Ratio
73
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...
73
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
110
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,...
110
01:16Bioequivalence: Overview
905
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
905
01:02Prescription, Nonprescription and Orphan Drugs
674
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
674
01:22Dose-Response Relationship: Potency and Efficacy
4.1K
The potency of a drug is the measure of its ability to produce a biological response and can be compared by looking at the half-maximum effective concentration or EC50 values of different drugs. A lower EC50 value indicates higher potency of the drug. In the dose–response curve of two antihypertensive drugs, candesartan and irbesartan, a significant difference is observed in their EC50 values. A lower EC50 value for candesartan indicates that it is more potent than irbesartan, as it...
4.1K
01:30Quantitative Aspects of Drug-Receptor Interaction
913
The receptor occupancy theory connects a drug's response to the number of occupied receptors. With higher drug concentrations, more receptors are occupied, leading to increased responses. The formation of drug-receptor complexes involves association and dissociation rates, which reach equilibrium when the forward and backward reactions are equal. The equilibrium association constant (Ka) and its inverse, the equilibrium dissociation constant (Kd), indicate drug affinity. Higher Ka and lower...
913