ReviewJournal of cardiovascular pharmacology2011
Pediatric cardiovascular drug trials, lessons learned.
Review in Journal of cardiovascular pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed.
- Angiotensin-Converting Enzyme Inhibitor Initiation and Dose Uptitration in Children With Cardiovascular Disease: A Retrospective Review of Standard Clinical Practice and a Prospective Randomized Clinical Trial.Journal of the American Heart Association · 2016Trial
- A scoping review of the evidence supporting antiarrhythmic use after paediatric cardiac surgery.Cardiology in the young · 2026Review
- Lack of children in public medical imaging data points to growing age bias in biomedical AI.Research square · 2025Article
- Lack of children in public medical imaging data points to growing age bias in biomedical AI.medRxiv : the preprint server for health sciences · 2025Article
- A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility.Contemporary clinical trials communications · 2023Article
- Improving representativeness in trials: a call to action from the Global Cardiovascular Clinical Trialists Forum.European heart journal · 2023Review
- Family Perspectives on Clinical Research for Pediatric Multiple Sclerosis: Enhancing Equity.Journal of patient experience · 2021Article
- Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart?Pharmaceutics · 2020Article
- Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act.The Journal of pediatrics · 2018Article
- 2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.Journal of the American College of Cardiology · 2017Article
- 2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.Circulation. Cardiovascular quality and outcomes · 2017Review
- Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval.The AAPS journal · 2013Article
- Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry.Pediatrics · 2012Article
- Article
- Opportunities and challenges in linking information across databases in pediatric cardiovascular medicine.Progress in pediatric cardiology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Few drugs have been labeled for pediatric cardiovascular indications, and many children with cardiac disease are prescribed drugs off-label. Recent initiatives have narrowed this gap, and as a result, there are an increasing number of cardiology trials in the pediatric population. Many studies, however, have either failed to show a dose response in children or have not shown efficacy in children when they have established efficacy in adults. Clinical trials are challenging in children; many factors such as lack of development of a liquid formulation, failure to fully incorporate pharmacokinetic information into trial design, poor dose selection, the lack of clinical equipoise, and the use of difficult surrogate and composite primary endpoints have led to the difficulties and failures observed in several pediatric cardiovascular trials. These lessons learned may help to inform future pediatric clinical trial development.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.