TY - JOUR
T1 - Profiling clinical research activity at an academic medical center by using institutional databases
T2 - Content analysis
AU - Langford, Aisha
AU - Sherman, Scott
AU - Thornton, Rachel
AU - Nightingale, Kira
AU - Kwon, Simona
AU - Chavis-Keeling, Deborah
AU - Link, Nathan
AU - Cronstein, Bruce
AU - Hochman, Judith
AU - Trachtman, Howard
N1 - Publisher Copyright:
©Aisha Langford, Scott Sherman, Rachel Thornton, Kira Nightingale, Simona Kwon, Deborah Chavis-Keeling, Nathan Link, Bruce Cronstein, Judith Hochman, Howard Trachtman.
PY - 2020/7
Y1 - 2020/7
N2 - Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
KW - Clinical studies as topic
KW - Database
KW - Geriatrics
KW - Pediatrics
KW - Vulnerable populations
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U2 - 10.2196/12813
DO - 10.2196/12813
M3 - Article
C2 - 32831180
AN - SCOPUS:85097902714
SN - 2369-2960
VL - 6
JO - JMIR Public Health and Surveillance
JF - JMIR Public Health and Surveillance
IS - 3
M1 - e12813
ER -