An evaluation of composite endpoints using data from the EXCITE trial

使用 EXCITE 试验的数据评估复合终点

• 批准号: 10645995
• 负责人: Mark R Conaway
• 金额: $ 8.08万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10645995
• 关键词: Affect; Agreement; Authorization documentation; Blinded; Characteristics; Clinical Trials; Consensus; Contracts; Data; Data Analyses; Data Set; Evaluation; Formulation; Funding; Future; Grant; Heterogeneity; Individual; Intervention; Investigation; Ischemia; Measures; Methods; National Institute of Child Health and Human Development; Outcome; Paper; Participant; Patients; Performance; Property; Role; Specimen; Statistical Methods; Structure; Testing; Therapeutic Intervention; Universities; Upper Extremity; Virginia; Work; arm; base; clinically relevant; data access; data hub; data resource; improved; insight; interest; intervention effect; longitudinal design; primary endpoint; primary outcome; randomized, clinical trials; repository; response; secondary analysis; secondary endpoint; trial design

In many clinical trials that assess the effect of an intervention, a single outcome does not adequately capture the effect of the intervention. In these cases, a composite outcome that combines information from several individual outcomes may be preferable. Although there have been a number of statistical tests proposed for composite outcomes, these methods tend to focus on the technical issues of maintain the type I error rate and the effects on statistical power. These are important considerations for designing trials, but do not address other key aspects, such as the characteristics of individual outcomes that would make up a clinical relevant composite measure. This proposal is in response to a Notice of Special Interest for using NICHD data resources in secondary data analyses. The proposal will do secondary analyses of the data from the EXCITE trial, available on the NICHD Data and Specimen Hub (DASH), to investigate the proposed statistical methods with actual clinical trial data, and to gain insight into the characteristics of individual outcomes that combine into a relevant composite outcome.

在评估干预效果的许多临床试验中，单个结果确实 不能充分捕获干预的影响。在这些情况下，复合材料 结合几个个人结果信息的结果可能是可取的。 尽管提出了许多统计测试的复合测试 结果，这些方法倾向于关注维护I类型的技术问题 错误率和对统计能力的影响。这些是重要的考虑因素 设计试验，但没有解决其他关键方面，例如 个人结果将构成临床相关的综合措施。这 提案是回应在使用NICHD数据资源的特殊利益的通知 二级数据分析。该提案将对来自数据的数据进行次要分析 激发试验，可在NICHD数据和标本中心（DASH）上使用，以调查 提出的具有实际临床试验数据的统计方法，并深入了解 组合成相关综合结果的个体结果的特征。