ReviewPaediatric drugs2015
Ethics of drug studies in the newborn.
Review in Paediatric drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed.
- Evaluation of Fentanyl-Emerged Adverse Events and Pharmacokinetics in Neonates: A Physiologically Based Pharmacokinetic Modeling Approach.Clinical pharmacokinetics · 2025Article
- Pediatric flecainide pharmacogenomics: a roadmap to delivering precision-based care to pediatrics arrhythmias.Frontiers in pharmacology · 2024Review
- Physiologically-based pharmacokinetic modeling of nafamostat to support dose selection for treatment of pediatric patients with COVID-19.Translational and clinical pharmacology · 2022Article
- Physiologically-Based Pharmacokinetic (PBPK) Modeling Providing Insights into Fentanyl Pharmacokinetics in Adults and Pediatric Patients.Pharmaceutics · 2020Article
- Physiologically-Based Pharmacokinetic (PBPK) Modeling of Buprenorphine in Adults, Children and Preterm Neonates.Pharmaceutics · 2020Article
- Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.Journal of clinical pharmacology · 2019Review
- Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.Clinical pharmacokinetics · 2019Review
- Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.PloS one · 2017Article
- Newborns still lack drug data to guide therapy.British journal of clinical pharmacology · 2016Article
- Ethics of studies of drugs in pregnancy.Paediatric drugs · 2015Review
- Creating a new ethical climate for drug research in children and pregnant women.Paediatric drugs · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drug studies in developing pediatric patients, especially newborns, create many ethical challenges that can be analyzed in terms of respect for persons, justice, and beneficence/maleficence as outlined in the Belmont Report. This report describes some of the ethical challenges in conducting drug studies in pediatric patients that must be considered when planning studies and offers some solutions to meet those challenges. Methods of optimal study design should be utilized to limit the number of patients and the number of blood samples. Parental permission should be obtained with equipoise, although the parents of a sick newborn may feel an internal pressure for their child to participate in a study of a new and potentially superior therapy. If appropriate to the study, consent before labor and delivery when parents are less stressed is optimal. It may be difficult or impossible to know all the risks and benefits accompanying studies in newborns due to the limited number of randomized controlled studies in this population. Many more carefully designed, randomized controlled studies of drugs are needed to address the therapeutic needs of the developing pediatric population. For sick newborns cared for in the neonatal intensive care unit (NICU), those studies should be better focused on the drugs used daily in their cares.
Indexed as
Identifiers
25354989What 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.