JMIR Publications

ABSTRACT

Background:

It is important to involve participants of all ages and subgroups in clinical research to ensure equal access and broad validity of the findings.

Objective:

We conducted a review of clinical research performed at NYU 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 initiation and nature of the study differed by age.

Methods:

Data for all studies which were IRB approved between January 1, 2014 - November 2, 2016 were obtained from the Research Navigator (RNav) system, which was launched in November 2013. One module provided details about the study protocol and a second the characteristics of individual participants. Research studies were classified as observational or interventional.

Results:

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 studies included both male and female participants. Of the remaining studies, those open only to girls or women were approximately three times as common as those confined to boys and men. 56-58% of projects focused on non-vulnerable patients. Among the special populations studied, children (12-15%) were the most common. Non-interventional 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.

Conclusions:

Pediatric age participants were the special population that was most often studied based on the number of projects that included children and adolescents. However, they were much less likely to be successfully enrolled into research studies compared to adults older than 65 years of age. Only 20% of the studies were interventional and 20-35% of participants in this category were from vulnerable populations. More studies are devoted to exclusively women’s versus men’s health issues.