Registration of trials in children: update of current international initiatives

Pandolfini, Chiara; Bonati, Maurizio; Sammons, Helen

doi:10.1136/adc.2008.148155

Cited by 5 publications

(4 citation statements)

References 27 publications

(23 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The paediatric research community has much to gain from the inclusive database of clinical trials in children that the ICTRP search portal provides through its Clinical Trials in Children search filter 26. Clinical trials registration allows for doctors and patients and their parents to inform themselves more adequately about trials open to recruitment 27.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic research in children: an analysis of registered records of clinical trials

2011

View full text Add to dashboard Cite

BackgroundReported off-label/unlicensed prescribing rates in children range from 11% to 80%. Research into pharmacokinetic profiles of children's medicines is essential in the creation of more knowledge on the safety and efficacy of medicines in children. This study investigated how often pharmacokinetic data are collected in clinical trials of medicines in children by analysing registered records of clinical trials.MethodsThe registered records of all clinical trials in children that were recruiting on 22 May 2009 were identified on the International Clinical Trials Registry Platform using a Clinical Trials in Children search filter. The records of trials in children below 12 years of age, in which the intervention was one or more medicines, were assessed for evidence that pharmacokinetic data would be collected.ResultsOf 1081 eligible trial records, 257 (24%) declared that pharmacokinetic data would be collected. Of these trials, 199 (77%) recruited in Northern America; recruitment in all other regions was below 20%. Trials recruited most often in children over 2 years of age (74%), and least often in newborn infants (32%). Most trials researched medicines in the field of cancer (29%). Trials investigated one-third of the medicines that were indicated as a priority for pharmacokinetic research by the European Medicines Agency.ConclusionsThere is a need for increased knowledge of the pharmacokinetic profiles of children's medicines. The amount of currently ongoing pharmacokinetic research does not seem to address adequately the lack of knowledge in this area. This study sets a baseline for monitoring of future progress on the amount of ongoing pharmacokinetic research in children.

show abstract

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic research in children: an analysis of registered records of clinical trials

2011

View full text Add to dashboard Cite

show abstract

“…The extensive research required by current standards of drug evaluation in order to register a specific product for paediatric use is often not supported by the profit-driven drug industry because children represent only a small part of the drug market [13]. Furthermore, the limited pediatric drug research that is carried out is often based on small-scale studies that lack the statistical power necessary to draw any firm conclusions concerning the real efficacy of the drugs or their long-term toxic effects [14]. Ethical conflicts are heightened where the toxicity of medicines may be different in children and adults, compounded by issues around informed consent and assent [15].…”

Section: Discussionmentioning

confidence: 99%

Off-label antibiotic use in children in three European countries

Porta

Esposito

Menson

et al. 2010

Eur J Clin Pharmacol

View full text Add to dashboard Cite

“…(Drug Evaluation in Children-network), a web- based register of trials on drug therapy in children was supported by the European Commission in 2006: data collection was oriented to the paediatric population, with a clear definition of age groups. The first data analysis was made available in 2008, but the database closed at the end of the project [ 73 , 74 ]. Other registries or platforms have limitations when it comes to pediatric trials: the International Clinical Trials WHO Registry Platform (ICTRP) [ 75 ], the EU Clinical Trials Register [ 76 ] containing information on interventional clinical trials since 2004.…”

Section: Discussionmentioning

confidence: 99%

Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

et al. 2017

View full text Add to dashboard Cite

BackgroundDespite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator.MethodsWe analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use.ResultsPlacebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details.ConclusionAlthough a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients.

show abstract

Registration of trials in children: update of current international initiatives

Cited by 5 publications

References 27 publications

Pharmacokinetic research in children: an analysis of registered records of clinical trials

Pharmacokinetic research in children: an analysis of registered records of clinical trials

Off-label antibiotic use in children in three European countries

Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

Contact Info

Product

Resources

About