A Qualitative Scoping Review of Early-Terminated Clinical Trials Sponsored by the Department of Veterans Affairs Cooperative Studies Program From 2010 to 2020.

IF 5.2 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Alexa Goldberg, Ludmila N Bakhireva, Kimberly Page, Adam M Henrie
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引用次数: 1

Abstract

Increasing attention has been paid to the risks and benefits of terminating large clinical trials before reaching prespecified targets, because such decisions can greatly affect the implementation of findings. The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) is a research infrastructure dedicated to conducting high-quality clinical research. A scoping review was performed to characterize barriers preventing the attainment of prespecified recruitment, statistical power, or sample-size targets in VA CSP trials. A trial was eligible for inclusion if the trial was sponsored by the VA CSP, primary findings were published within the last 10 years, and a decision was made to terminate enrollment or follow-up before meeting a priori recruitment or endpoint targets. In 11 of 29 included trials (37.9%), a decision was made to terminate the trial early. The most common reason for early termination was related to under-recruitment (n = 5). Other reasons included early detection of safety signals (n = 2), futility (n = 1), and benefit (n = 1). This review highlights recruitment as a critical facet of trial conduct that may hinder the production of high-quality data and thus warrant additional attention. Solutions to enhance recruitment now implemented by the VA CSP, including dedicated enrollment infrastructure and screening facilitated by informatics approaches, show promise in reducing this cause for early termination.

2010年至2020年退伍军人事务部合作研究项目赞助的早期终止临床试验的定性范围审查。
人们越来越关注在达到预先指定的目标之前终止大型临床试验的风险和益处,因为这样的决定会极大地影响研究结果的实施。退伍军人事务部(VA)合作研究计划(CSP)是一个致力于进行高质量临床研究的研究基础设施。进行了范围界定审查,以确定在VA CSP试验中阻碍实现预先指定的招募、统计能力或样本量目标的障碍。如果试验由VA CSP赞助,主要研究结果在过去10年内公布,并且在达到先验招募或终点目标之前决定终止招募或随访,则该试验有资格入选。在29项纳入的试验中,有11项(37.9%)决定提前终止试验。提前终止合同的最常见原因与招聘不足有关(n=5)。其他原因包括早期检测到安全信号(n=2)、无效性(n=1)和益处(n=1)。这项审查强调,招聘是审判行为的一个关键方面,可能会阻碍高质量数据的产生,因此需要更多关注。VA CSP目前实施的加强招聘的解决方案,包括专门的招生基础设施和信息学方法促进的筛查,有望减少提前终止的原因。
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来源期刊
Epidemiologic Reviews
Epidemiologic Reviews 医学-公共卫生、环境卫生与职业卫生
CiteScore
8.10
自引率
0.00%
发文量
10
期刊介绍: Epidemiologic Reviews is a leading review journal in public health. Published once a year, issues collect review articles on a particular subject. Recent issues have focused on The Obesity Epidemic, Epidemiologic Research on Health Disparities, and Epidemiologic Approaches to Global Health.
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