Scholars@Duke publication: Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.

Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.

Publication , Journal Article

Hill, KD; Chiswell, K; Califf, RM; Pearson, G; Li, JS

Published in: Am Heart J

June 2014

BACKGROUND: ClinicalTrials.gov is an National Institutes of Health-sponsored registry of federally and privately funded trials. We sought to determine fundamental characteristics of registered pediatric cardiovascular trials (PCVTs). METHODS: A data set including 68,134 interventional clinical trials was downloaded from ClinicalTrials.gov and entered into a relational database. Aggregate data from PCVTs were compared with other trial specialties. Multivariable logistic regression was used to evaluate factors associated with improved trial quality metrics including blinding and randomization. RESULTS: Between July 1, 2005, and September 27, 2010, 5035 (7%) registered trials targeted pediatric populations, including 213 PCVTs (4.2%), 1,176 pediatric infectious disease trials (23%), 664 pediatric mental health trials (13%), and 346 pediatric hematology/oncology trials (7%). Median (interquartile range) PCVT enrollment was 65 subjects (36-186) and median study duration was 2.3 years (1.3-3.7). The most common PCVTs targeted acquired diseases including hypertension (n = 41, 14%), obesity (n = 26, 9%), pulmonary hypertension (n = 25, 9%), and dyslipidemia (n = 19, 7%). Important factors associated with improved quality metrics included National Institutes of Health as opposed to industry funding (OR, 1.9; P < .0001); trial location (trials with both US and foreign enrollment vs trials with US only or foreign only enrollment, P = .02) and trials restricted to younger children as opposed to trials including adolescents (OR, 1.4; P < .0001). CONCLUSION: PCVTs represent a small proportion of clinical trials relative to other pediatric subspecialties. Most PCVTs tend to parallel adult morbidities while there is a relative paucity of trials focused on congenital heart disease. These data may be useful to stakeholders in informing decisions regarding the conduct of PCVTs, and to provide insight into mechanisms to advance PCVT infrastructure.

Duke Scholars

Author Kevin Dennis Hill Pediatrics, Cardiology

Author Karen Chiswell

Author K.K. Lam

Author Jennifer Shiunroh Li Pediatrics, Cardiology

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Published In

Am Heart J

DOI

10.1016/j.ahj.2014.02.002

EISSN

1097-6744

Publication Date

June 2014

Volume

167

Issue

Start / End Page

921 / 9.e2

Location

United States

Related Subject Headings

United States
Sample Size
Registries
Obesity
National Institutes of Health (U.S.)
Logistic Models
Infant, Newborn
Infant
Hypertension, Pulmonary
Hypertension

Citation

APA

Chicago

ICMJE

MLA

NLM

Hill, K. D., Chiswell, K., Califf, R. M., Pearson, G., & Li, J. S. (2014). Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov. Am Heart J, 167(6), 921-9.e2. https://doi.org/10.1016/j.ahj.2014.02.002

Hill, Kevin D., Karen Chiswell, Robert M. Califf, Gail Pearson, and Jennifer S. Li. “Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.” Am Heart J 167, no. 6 (June 2014): 921-9.e2. https://doi.org/10.1016/j.ahj.2014.02.002.

Hill KD, Chiswell K, Califf RM, Pearson G, Li JS. Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov. Am Heart J. 2014 Jun;167(6):921-9.e2.

Hill, Kevin D., et al. “Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.” Am Heart J, vol. 167, no. 6, June 2014, pp. 921-9.e2. Pubmed, doi:10.1016/j.ahj.2014.02.002.

Hill KD, Chiswell K, Califf RM, Pearson G, Li JS. Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov. Am Heart J. 2014 Jun;167(6):921–9.e2.