International Clinical Trials Registry Platform, Department of Research Policy and Cooperation, World Health Organization, Geneva, Switzerland.
BMJ Open. 2011 Aug 9;1(1):e000221. doi: 10.1136/bmjopen-2011-000221.
Reported 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.
The 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.
Of 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.
There 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.
据报道，儿童的标签外/无许可处方率在 11%至 80%之间。对儿童药物药代动力学特征的研究对于增加儿童用药安全性和疗效的知识至关重要。本研究通过分析已注册的临床试验记录，调查了儿童药物临床试验中收集药代动力学数据的频率。
在 2009 年 5 月 22 日，使用儿童临床试验搜索过滤器，在国际临床试验注册平台上确定了所有正在招募儿童的临床试验的已注册记录。评估了年龄在 12 岁以下、干预措施为一种或多种药物的儿童临床试验记录，以确定是否会收集药代动力学数据。
在 1081 份合格的试验记录中，有 257 份（24%）声明将收集药代动力学数据。在这些试验中，199 项（77%）在北美招募；在所有其他地区的招募率都低于 20%。试验招募的儿童最常见的是 2 岁以上的儿童（74%），而新生儿（32%）的招募最少。大多数试验都在癌症领域研究药物（29%）。试验研究了欧洲药品管理局确定为药代动力学研究重点的三分之一的药物。
需要更多地了解儿童药物的药代动力学特征。目前正在进行的药代动力学研究的数量似乎不足以解决这方面缺乏知识的问题。本研究为监测未来儿童药代动力学研究的进展情况奠定了基础。
