Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov

Hill, Kevin D.; Chiswell, Karen; Califf, Robert M.; Pearson, Gail D.; Li, Jennifer S.

doi:10.1016/j.ahj.2014.02.002

Cited by 33 publications

(32 citation statements)

References 13 publications

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“…The methods of defining derived variables have been described previously15 18 and are briefly summarised below. All trials were divided into six different groups by the funding sources according to the information in the ‘Sponsor_Collaborators’ and ‘Funded_By’ sections: NIH, industry, other, US federal (excluding NIH), university/college, hospital and other sources.…”

Section: Methodsmentioning

confidence: 99%

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry

Zhang

et al. 2016

BMJ Open

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ObjectivePhase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data.MethodsA data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation.ResultsA total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor.ConclusionsPhase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task.

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Section: Methodsmentioning

confidence: 99%

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry

Zhang

et al. 2016

BMJ Open

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“…Bourgeois examined several high disease burden conditions among children in high-, middle-, and low-income countries and found that 60% of disease burden was attributable to children, but only 12% of studies in ClinicalTrials.gov were pediatric trials [19]. Hill’s analysis of the portfolio on ClinicalTrials.gov [20] revealed a low number (116) of pediatric cardiovascular clinical trials relative to 2561 adult cardiovascular trials. Of the pediatric cardiovascular trials identified, approximately one-third were focused on diseases that may be amenable to testing a new drug, such as hypertension and dyslipidemia, rather than CHD.…”

Section: Discussionmentioning

confidence: 99%

Trends in National Institutes of Health-Funded Congenital Heart Disease Research from 2005 to 2015

et al. 2017

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In an era of ongoing need for research to enable evidence-based care for the expanding population with congenital heart disease (CHD), economic fluctuations have impacted research funding. We characterize trends in NIH-funded CHD research from 2005 to 2015. We searched the NIH RePORTER database from 2005 to 2015 using the terms “congenital heart” and “cardiac morphogenesis”. Projects were characterized by year, institute, mechanism, costs, type and topic, and funding trends were analyzed. From 2005 to 2015, NIH funded 633 CHD research projects with total costs of $991 million. The National Heart, Lung, and Blood Institute funded 83% of CHD projects (528, $857 million). The R01 mechanism was used for 45% of projects (288, $421 million). Projects were 70% basic/early translational research, 27% clinical research, and 3% both. Cardiac developmental biology was the most common topic (52%), followed by technology/therapy development (15%), and diagnosis/management (12%). The total number of CHD projects ranged from 153 to 221 per year (30–58 new projects/year), and costs per year ranged from $58 to $116 million. The number of projects and total costs increased until 2012, but decreased again thereafter. CHD research did not experience as much erosion as overall NIH purchasing power; in constant dollars, CHD research funding levels in 2015 were $12 million higher than those in 2005. The NIH supported a diverse portfolio of CHD projects from 2005 to 2015. Support of CHD research projects trended upward until 2012, but declined thereafter due to fiscal austerity measures.

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“…There are fewer pediatric cardiovascular trials than in other pediatric specialties, and many important diseases remain understudied 48. It is therefore important to both increase the number of trials and conduct them with efficiency and at a reasonable cost.…”

Section: Approaches To Improving Clinical Trials In Children With Carmentioning

confidence: 99%

Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi‐Stakeholder Think Tank

Török

Kannankeril

et al. 2018

JAHA

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Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov

Cited by 33 publications

References 13 publications

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry

Trends in National Institutes of Health-Funded Congenital Heart Disease Research from 2005 to 2015

Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi‐Stakeholder Think Tank

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