SynthesisEuropean journal of clinical pharmacology2012
Systematic review of safety in paediatric drug trials published in 2007.
Synthesis in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Safety of medical interventions in children versus adults.Pediatrics · 2014Pooled it
- Gestational Paracetamol (Acetaminophen) Toxicity Induces Behavioral and Structural Brain Defects in Rats.Current issues in molecular biology · 2026Article
- Value of a web-based pediatric drug information system to prevent serious adverse drug reactions in child and adolescent psychiatry.Journal of neural transmission (Vienna, Austria : 1996) · 2023Article
- Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice.Pharmacopsychiatry · 2022Article
- Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital.Frontiers in pharmacology · 2021Article
- A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily.Frontiers in pharmacology · 2020Article
- Article
- Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre.Pharmacoepidemiology and drug safety · 2019Article
- Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia.Frontiers in pharmacology · 2017Article
- Drug Utilization on Neonatal Wards: A Systematic Review of Observational Studies.Frontiers in pharmacology · 2017Article
- A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.PloS one · 2016Article
- Paediatric clinical pharmacology in the UK.Archives of disease in childhood · 2014Review
- Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety.European journal of pediatrics · 2013Review
- Treatment duration with selective serotonin reuptake inhibitors among children and adolescents in Finland: a nationwide register study.European journal of clinical pharmacology · 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 at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is now greater involvement of children in drug trials to ensure that paediatric medicines are supported by sound scientific evidence. The safety of the participating children is of paramount importance. Previous research shows that these children can suffer moderate and severe adverse drug reactions (ADRs) in clinical trials, yet very few of the trials designated a data safety monitoring board (DSMB) to oversee the trial.
methodsSafety data from a systematic review of paediatric drug randomised controlled trials (RCTs) published in 2007 were analysed. All reported adverse events (AEs) were classified and assessed to determine whether an ADR had been experienced. ADRs were then categorised according to severity. Each trial report was examined as to whether an independent DSMB was in place.
resultsOf the 582 paediatric drug RCTs analysed, 210 (36%) reported that a serious AE had occurred, and in 15% mortality was reported. ADRs were detected in more than half of the RCTs (305); 66 (11%) were severe, and 79 (14%) were moderate. Severe ADRs involved a wide range of organ systems and were frequently associated with cytotoxic drugs, antiparasitics, anticonvulsants and psychotropic drugs. Two RCTs reported significantly higher mortality rates in the treatment group. Only 69 (12%) of the RCTs stated there was a DSMB. DSMBs terminated five RCTs and changed the protocol in one.
conclusionsChildren participating in drug RCTs experience a significant amount and a wide range of ADRs. DSMBs are needed to ensure the safety of paediatric participants in clinical drug trials.
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.