ReviewBritish journal of clinical pharmacology2015
Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct.
Review in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed.
- Data-Related and Methodological Challenges in Assessing the Cost-Effectiveness of Traditional and Genomic Newborn Screening Programs.Applied health economics and health policy · 2026Review
- Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): A Feasibility Randomized Controlled Trial.Children (Basel, Switzerland) · 2025Article
- Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches.Trials · 2025Article
- Group B streptococcus in pregnant women and neonates in Africa: a scoping review.BMJ public health · 2025Article
- Delta-S-Cys-Albumin as a Marker of Pediatric Biospecimen Integrity.Biopreservation and biobanking · 2024Article
- Simulation-based development: shaping clinical procedures for extra-uterine life support technology.Advances in simulation (London, England) · 2023Article
- Subgroup analysis of phase 2 study of ceftolozane/tazobactam in neonates and young infants with pyelonephritis.Microbiology spectrum · 2023Article
- Recommendations by the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Working Group on preparedness of clinical trials about paediatric medicines process.Archives of disease in childhood · 2021Review
- The culture of research communication in neonatal intensive care units: key stakeholder perspectives.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Article
- Saudi pediatric residents' confidence in handling ethical situations and factors influencing it.International journal of pediatrics & adolescent medicine · 2021Article
- Challenges in conducting paediatric trials with off-patent drugs.Contemporary clinical trials communications · 2021Article
- Paediatric clinical research in Europe: an insight on experts' needs and perspectives.Contemporary clinical trials communications · 2021Article
- Barriers and Challenges in Performing Pharmacokinetic Studies to Inform Dosing in the Neonatal Population.Pharmacy (Basel, Switzerland) · 2020Review
- Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective.Journal of perinatology : official journal of the California Perinatal Association · 2019Article
- Recommendations for the design of therapeutic trials for neonatal seizures.Pediatric research · 2019Article
- Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.Clinical pharmacokinetics · 2019Review
- Paediatric prescribing: why children are not small adults.British journal of clinical pharmacology · 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
1 author.
Funding
Abstract
In the past, there has been a perception that ethical and practical problems limit the opportunities for research in neonates. This perception is no longer appropriate. It is now clear that research about the medicines used in neonates is an ethical requirement. It is possible to conduct high quality research in neonates if the research team adapt to the characteristics of this population. Good practice involves respecting the specific needs of newborn babies and their families by adopting relevant approaches to study design, recruitment, pharmacokinetic studies and safety assessment. Neonatal units have a unique culture that requires careful development in a research setting. Clinical investigators need to recognize the clinical and ethical imperative to conduct rigorous research. Industry needs to engage with neonatal networks early in the process of drug development, preferably before contacting regulatory agencies. Follow-up over 3-5 years is essential for the evaluation of medicines in neonates and explicit funding for this is required for the assessment of the benefit and risk of treatments given to sick newborn babies. The views of parents must be central to the development of studies and the research agenda. Ethical and practical problems are no longer barriers to research in neonates. The current challenges are to disseminate good practice and maximize capacity in order to meet the need for research among newborn babies.
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.