New York University Langone Health, New York, NY, United States.
JMIR Public Health Surveill. 2020 Aug 24;6(3):e12813. doi: 10.2196/12813.
It is important to monitor the scope of clinical research of all types, to involve participants of all ages and subgroups in studies that are appropriate to their condition, and to ensure equal access and broad validity of the findings.
We conducted a review of clinical research performed at New York University with the following objectives: (1) to determine the utility of institutional administrative data to characterize clinical research activity; (2) to assess the inclusion of special populations; and (3) to determine if the type, initiation, and completion of the study differed by age.
Data for all studies that were institutional review board-approved between January 1, 2014, and November 2, 2016, were obtained from the research navigator system, which was launched in November 2013. One module provided details about the study protocol, and another module provided the characteristics of individual participants. Research studies were classified as observational or interventional. Descriptive statistics were used to assess the characteristics of clinical studies across the lifespan, by type, and over time.
A total of 22%-24% of studies included children (minimum age <18 years) and 4%-5% focused exclusively on pediatrics. Similarly, 64%-72% of studies included older patients (maximum age >65 years) but only 5%-12% focused exclusively on geriatrics. Approximately 85% of the studies included both male and female participants. Of the remaining studies, those open only to girls or women were approximately 3 times as common as those confined to boys or men. A total of 56%-58% of projects focused on nonvulnerable patients. Among the special populations studied, children (12%-15%) were the most common. Noninterventional trial types included research on human data sets (24%), observational research (22%), survey research (16%), and biospecimen research (8%). The percentage of projects designed to test an intervention in a vulnerable population increased from 17% in 2014 to 21% in 2015.
Pediatric participants were the special population that was most often studied based on the number of registered projects that included children and adolescents. However, they were much less likely to be successfully enrolled in research studies compared with adults older than 65 years. Only 20% of the studies were interventional, and 20%-35% of participants in this category were from vulnerable populations. More studies are exclusively devoted to women's health issues compared with men's health issues.
监测各类临床研究的范围、使各年龄段和亚组的参与者参与到适合其病情的研究中、并确保平等获取和广泛适用研究结果非常重要。
我们对纽约大学进行的临床研究进行了审查，目的如下：(1) 确定机构行政数据在描述临床研究活动方面的效用；(2) 评估特殊人群的纳入情况；(3) 确定研究的类型、启动和完成是否因年龄而异。
从 2013 年 11 月推出的研究导航系统中获取了 2014 年 1 月 1 日至 2016 年 11 月 2 日期间机构审查委员会批准的所有研究的数据。一个模块提供了研究方案的详细信息，另一个模块提供了个别参与者的特征。研究研究分为观察性研究或干预性研究。通过按类型和随时间推移对整个生命周期的临床研究的特征进行描述性统计来评估。
共有 22%-24%的研究纳入了儿童（最小年龄<18 岁），4%-5%的研究专门针对儿科。同样，64%-72%的研究纳入了老年患者（最大年龄>65 岁），但只有 5%-12%的研究专门针对老年医学。大约 85%的研究包括男性和女性参与者。其余研究中，仅对女孩或女性开放的研究约为仅对男孩或男性开放的研究的三倍。共有 56%-58%的项目侧重于非脆弱患者。在所研究的特殊人群中，儿童（12%-15%）最为常见。非干预性试验类型包括人类数据集研究（24%）、观察性研究（22%）、调查研究（16%）和生物样本研究（8%）。旨在测试脆弱人群中干预措施的项目比例从 2014 年的 17%增加到 2015 年的 21%。
根据纳入儿童和青少年的注册项目数量，儿科参与者是最常研究的特殊人群。然而，与 65 岁以上的成年人相比，他们成功参与研究的可能性要小得多。只有 20%的研究是干预性的，这一类别中有 20%-35%的参与者来自脆弱人群。与男性健康问题相比，更多的研究专门针对女性健康问题。
