U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.
U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.
Contemp Clin Trials. 2021 May;104:106355. doi: 10.1016/j.cct.2021.106355. Epub 2021 Mar 10.
With the growing use of online study management systems and rapid availability of data, timely data review and quality assessments are necessary to ensure proper clinical trial implementation. In this report we describe central monitoring used to ensure protocol compliance and accurate data reporting, implemented during a large phase 3 clinical trial.
The Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) study A5349 (S31) is an international, multi-site, randomized, open-label, controlled, non-inferiority phase 3 clinical trial comparing two 4-month regimens to a standard 6 month regimen for treatment of drug-susceptible tuberculosis (TB) among adolescents and adults with a sample size of 2500 participants.
Central monitoring utilized primary study data in a five-tiered approach, including (1) real-time data checks & topic-specific intervention reports, (2) missing forms reports, (3) quality assurance metrics, (4) critical data reports and (5) protocol deviation identification, aimed to detect and resolve quality challenges. Over the course of the study, 240 data checks and reports were programed across the five tiers used.
This use of primary study data to identify issues rapidly allowed the study sponsor to focus quality assurance and data cleaning activities on prioritized data, related to protocol compliance and accurate reporting of study results. Our approach enabled us to become more efficient and effective as we informed sites about deviations, resolved missing or inconsistent data, provided targeted guidance, and gained a deeper understanding of challenges experienced at clinical trial sites.
This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015.
随着在线研究管理系统的广泛应用和数据的快速获取，及时进行数据审查和质量评估对于确保临床试验的正确实施是必要的。本报告描述了在一项大型 3 期临床试验中为确保方案遵守和准确报告数据而实施的中心监测。
结核病试验联盟（TBTC）研究 31/艾滋病临床试验组（ACTG）研究 A5349（S31）是一项国际、多中心、随机、开放标签、对照、非劣效性 3 期临床试验，比较了两种 4 个月方案与标准 6 个月方案治疗青少年和成人耐多药结核病（TB）的疗效，样本量为 2500 名参与者。
中心监测采用了原始研究数据的五级方法，包括（1）实时数据检查和专题干预报告，（2）缺失表单报告，（3）质量保证指标，（4）关键数据报告和（5）方案偏离识别，旨在发现和解决质量挑战。在研究过程中，对五个层次共进行了 240 次数据检查和报告编程。
这种使用原始研究数据快速识别问题的方法使研究赞助商能够将质量保证和数据清理活动集中在与方案遵守和准确报告研究结果相关的优先数据上。我们的方法使我们能够更加高效和有效地了解偏差、解决缺失或不一致的数据、提供有针对性的指导，并深入了解临床试验现场遇到的挑战。
该试验于 2015 年 4 月 8 日在 ClinicalTrials.gov（标识符：NCT02410772）注册。
