Duke University Medical Center, Department of Pediatrics, Division of Cardiology, PO Box 17969, Durham, NC 27715, USA.
Pediatrics. 2010 Sep;126(3):e687-92. doi: 10.1542/peds.2010-0098. Epub 2010 Aug 23.
We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Provision, which provides economic incentives to pharmaceutical companies to conduct drug studies with children.
Published studies containing the main results of trials conducted in 1998-2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported.
Overall, 174 trials were included (sample size: 8-27 065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of trials that did report such information, 65% were conducted in >or=1 country outside the United States, and 11% did not include any sites in the United States. Fifty-four countries were represented, and 38% of trials enrolled patients in >or=1 site located in a developing/transition country, including more than one-third of infectious disease, cardiovascular, and allergy/immunology trials.
The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside the United States, and more than one-third of trials enrolled patients in developing/transition countries.
我们评估了根据美国儿科独占条款进行的已发表研究的设定，该条款为制药公司提供经济激励，以在儿童中进行药物研究。
纳入了在儿科独占条款下于 1998 年至 2007 年进行的主要结果试验的已发表研究。从每项研究中提取数据并进行描述，包括所研究药物的治疗领域、入组患者的数量、地点数量以及如果有报告的话，研究的进行地点。
总共纳入了 174 项试验（样本量：8-27065 名患者）；9%的试验没有报告任何关于研究地点或地点数量的信息。在报告了这些信息的试验中，65%是在美国以外的>或=1 个国家进行的，11%的试验没有包括美国的任何地点。共有 54 个国家参与，38%的试验在>或=1 个位于发展中/转型国家的地点招募了患者，包括三分之一以上的传染病、心血管和过敏/免疫学试验。
根据儿科独占条款进行的已发表儿科试验大多包括美国以外的地点，超过三分之一的试验在发展中/转型国家招募了患者。
