title: Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatrics, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: kevin.hill@duke.edu.
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Hill
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.affiliation: Duke Clinical Research Institute, Durham, NC; Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC; Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Gail
authors.initials: G
authors.lastname: Pearson
authors.affiliation: Department of Pediatrics, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D002318:Cardiovascular Diseases; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000191:economics / Q000706:statistics & numerical data*; D016208:Databases, Factual; D050171:Dyslipidemias; D035082:Federal Government; D005380:Financing, Government / Q000706:statistics & numerical data; D006801:Humans; D006973:Hypertension; D006976:Hypertension, Pulmonary; D007223:Infant; D007231:Infant, Newborn; D016015:Logistic Models; D009316:National Institutes of Health (U.S.); D009765:Obesity; D012042:Registries; D018401:Sample Size; D014481:United States