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Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov

Kevin D Hill1, Karen Chiswell2, Robert M Califf3

  • 1Department of Pediatrics, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.

American Heart Journal
|June 4, 2014
PubMed

Insights

Pediatric cardiovascular trials (PCVTs) are a small fraction of registered clinical trials, often focusing on acquired conditions rather than congenital heart disease. Factors like NIH funding and enrollment of younger children improve trial quality.

Area of Science:

  • Cardiovascular Research
  • Pediatric Clinical Trials
  • Health Services Research

Background:

  • ClinicalTrials.gov, a registry of federally and privately funded trials, was utilized to analyze pediatric cardiovascular trials (PCVTs).
  • Understanding the characteristics of PCVTs is crucial for advancing pediatric cardiovascular research and care.

Purpose of the Study:

  • To determine the fundamental characteristics of registered pediatric cardiovascular trials (PCVTs).
  • To compare PCVTs with other pediatric trial specialties and identify factors influencing trial quality.

Main Methods:

  • A dataset of 68,134 interventional clinical trials was downloaded from ClinicalTrials.gov.
  • Aggregate data from 213 PCVTs were compared with other trial specialties using multivariable logistic regression to assess factors associated with improved quality metrics like blinding and randomization.

Main Results:

  • PCVTs constituted 4.2% of pediatric trials (213 out of 5035) registered between 2005 and 2010.
  • Common PCVT targets included hypertension, obesity, pulmonary hypertension, and dyslipidemia, with a median enrollment of 65 subjects and study duration of 2.3 years.
  • National Institutes of Health funding, multi-national enrollment, and focusing on younger children were associated with improved trial quality metrics.

Conclusions:

  • PCVTs represent a limited proportion of pediatric clinical trials, with a focus on acquired conditions over congenital heart disease.
  • The findings highlight the need to enhance PCVT infrastructure and inform stakeholders for better trial conduct.
  • Data suggest that NIH funding and broader trial designs contribute to higher quality pediatric cardiovascular research.
Abstract

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