University of Tennessee Health Science Center, 881 Madison Avenue, #340, Memphis, TN, 38163, USA,
Int J Clin Pharm. 2013 Dec;35(6):1203-7. doi: 10.1007/s11096-013-9849-x. Epub 2013 Sep 19.
Some medicines regulatory authorities are encouraging research in pediatrics. However, children are a vulnerable population, and previous studies have suggested that research is increasingly being conducted outside of developed countries.
The purpose of this study is to determine the location of trials in the pediatric population with human immunodeficiency virus (HIV).
Not applicable.
Clinical trials registered in the largest international clinical trials registry (clinicaltrials.gov) evaluating antiretrovirals in pediatric HIV infected patients were included. Data were collected on the location, funding, study purpose, design, initiation date, age of subjects, and medication classes tested.
We assessed frequencies of characteristics of pediatric HIV trials registered in the clinicaltrials.gov database.
Overall, 288 studies were included in the analysis. Most trials were conducted in ages 12-17 years (83 %), followed by studies in those <6 years (25 %) and 6-11 years (21 %). The location of most trials included at least one site in developed countries (83 %). The number of trials completed exclusively in developing countries increased from 1989 to 2011.
The majority of pediatric antiretroviral trials registered in clinicaltrials.gov were conducted in adolescent subjects in developed countries. The number of pediatric HIV studies in developing countries increased while studies conducted in developed countries decreased similar to trends of HIV.
一些药品监管机构鼓励开展儿科研究。然而，儿童是一个弱势群体，先前的研究表明，研究越来越多地在发达国家以外进行。
本研究旨在确定在感染人类免疫缺陷病毒（HIV）的儿科人群中进行的试验的地点。
不适用。
纳入在最大的国际临床试验注册库（clinicaltrials.gov）中注册的评估抗逆转录病毒药物在儿科 HIV 感染患者中的临床试验。收集的资料包括试验地点、资金来源、研究目的、设计、启动日期、受试者年龄和测试的药物类别。
我们评估了在 clinicaltrials.gov 数据库中注册的儿科 HIV 试验的特征频率。
共有 288 项研究纳入分析。大多数试验是在 12-17 岁年龄组进行（83%），其次是<6 岁年龄组（25%）和 6-11 岁年龄组（21%）。大多数试验的地点至少包括一个发达国家的试验点（83%）。2009 年至 2011 年，完全在发展中国家进行的试验数量有所增加。
在 clinicaltrials.gov 中注册的大多数儿科抗逆转录病毒试验是在发达国家的青少年中进行的。发展中国家的儿科 HIV 研究数量增加，而发达国家的研究数量减少，这与 HIV 的趋势相似。
