Gresham Gillian K, Ehrhardt Stephan, Meinert Jill L, Appel Lawrence J, Meinert Curtis L
1 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
2 Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.
Clin Trials. 2018 Feb;15(1):65-74. doi: 10.1177/1740774517727742. Epub 2017 Sep 7.
Background The National Institutes of Health is one of the largest biomedical research agencies in the world. Clinical trials are an important component of National Institutes of Health research efforts. Given the recent updates in National Institutes of Health trial reporting requirements, more information regarding the current state of National Institutes of Health-funded clinical trials is warranted. The objective of this analysis was to describe characteristics and trends of clinical trials funded by the National Institutes of Health over time and by Institutes and Centers of the National Institutes of Health. Methods Interventional studies funded by the National Institutes of Health and registered in ClinicalTrials.gov between 2005 and 2015 were included in the analysis. Trials were identified from the 27 March 2016 Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database. A descriptive analysis of trials by year and National Institutes of Health Institute/Center was performed. Results There were 12,987 National Institutes of Health-funded clinical trials registered between 2005 and 2015. There were 1,580, 1,116, and 930 trials registered in 2005, 2010, and 2015, respectively. The majority were early-development trials (phases 0, 1, or 2; 53%), randomized (61%), and single-center (63%). Trial demographics have remained unchanged over time. Median trial sample size was 64 (interquartile range 29-192) with 10% of trials enrolling ≥500 participants. Most trials were completed within 5 years of enrollment start (69%). Trial characteristics varied considerably across National Institutes of Health Institutes and Centers. Results were reported under the assumptions that most National Institutes of Health-funded trials are registered in ClinicalTrials.gov and that trials are being registered completely and accurately. Conclusion In conclusion, there has been a decline in the number of trials being funded over time, explained in part by a relatively constant budget, increases in trial costs, or other factors that cannot be quantified. National Institutes of Health-funded trials are relatively small and tend to be single-centered. There are substantial differences in the number and types of trials done by Institutes and Centers within the National Institutes of Health.
美国国立卫生研究院是世界上最大的生物医学研究机构之一。临床试验是美国国立卫生研究院研究工作的重要组成部分。鉴于美国国立卫生研究院试验报告要求的最新更新，有必要获取更多关于由其资助的临床试验现状的信息。本分析的目的是描述美国国立卫生研究院资助的临床试验随时间以及按美国国立卫生研究院各研究所和中心划分的特征和趋势。
分析纳入了2005年至2015年期间由美国国立卫生研究院资助并在ClinicalTrials.gov上注册的干预性研究。试验从2016年3月27日ClinicalTrials.gov数据库的临床试验转化倡议汇总分析中识别。对按年份和美国国立卫生研究院研究所/中心划分的试验进行了描述性分析。
2005年至2015年期间有12,987项由美国国立卫生研究院资助的临床试验注册。2005年、2010年和2015年分别有1,580项、1,116项和930项试验注册。大多数是早期开发试验（0期、1期或2期；53%），随机试验（61%），且为单中心试验（63%）。试验人口统计学特征随时间保持不变。试验样本量中位数为64（四分位间距29 - 192），10%的试验招募≥500名参与者。大多数试验在入组开始后的5年内完成（69%）。不同美国国立卫生研究院研究所和中心的试验特征差异很大。结果是在大多数由美国国立卫生研究院资助的试验在ClinicalTrials.gov上注册且试验完全准确注册的假设下报告的。
总之，随着时间推移，资助的试验数量有所下降，部分原因是预算相对稳定、试验成本增加或其他无法量化的因素。由美国国立卫生研究院资助的试验规模相对较小且往往是单中心的。美国国立卫生研究院各研究所和中心进行的试验数量和类型存在显著差异。
