Pharmacy and Paediatric Intensive Care Departments, Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust, Westminster Bridge Road, London, UK.
Paediatr Drugs. 2011 Aug 1;13(4):257-65. doi: 10.2165/11590350-000000000-00000.
Global pediatric research has recently received increased attention by health professionals, and research and government institutions. Since the approval of the FDA Pediatric Exclusivity Provision and the EU Paediatric Regulation, pharmaceutical companies have begun to look to developing/transitional countries for international pediatric research collaboration as a way of facilitating the recruitment of patients to clinical trials. Among countries identified as being 'developing/transitional' some were in the North, Central, and South American regions.
The aim of this study was to ascertain views from local practitioners on awareness and understanding of pediatric clinical research and to clarify resources and training required by pediatricians engaging in such research in the North, Central, and South American regions. A brief survey was disseminated via Sociedad Iberoamericana de Neonatología (SIBEN) and several other randomly selected pediatric institutions. This survey provided information for a Paediatric Global Research meeting at WorldPharma 2010 (Copenhagen, Denmark).
Pediatricians (n = 55) from seven countries in Latin America and Guyana replied to the survey. They appeared to be enthusiastic about embracing the opportunity to participate in meaningful research to improve treatment of children worldwide. However, some challenges remain to be addressed around good clinical practice in the conduct of trials, education, and training of professionals, and the availability and use of resources.
The survey indicated a considerable depth of interest in the improvement of the pediatric clinical research environment in Latin America. There is some momentum toward the development of a Latin American network for the facilitation and supervision of pediatric clinical research.
全球儿科研究最近受到卫生专业人员和研究及政府机构的更多关注。自 FDA 儿科专有权规定和欧盟儿科法规获得批准以来，制药公司已开始将发展中国家和转型期国家视为国际儿科研究合作的对象，以促进临床试验患者的招募。在被确定为“发展中国家和转型期国家”的国家中，有些位于北美、中美和南美地区。
本研究旨在了解当地从业者对儿科临床研究的认识和理解，并明确在北美、中美和南美地区从事此类研究的儿科医生所需的资源和培训。通过 Sociedad Iberoamericana de Neonatología（SIBEN）和其他几个随机选择的儿科机构分发了一份简短的调查。该调查为 2010 年 WorldPharma（丹麦哥本哈根）举行的儿科全球研究会议提供了信息。
来自拉丁美洲和圭亚那的七个国家的儿科医生（n=55）对该调查做出了回应。他们似乎热衷于抓住机会参与有意义的研究，以改善全世界儿童的治疗。然而，在临床试验的良好临床实践、教育和专业人员培训以及资源的可用性和使用方面，仍存在一些挑战需要解决。
该调查表明，拉丁美洲改善儿科临床研究环境的兴趣相当浓厚。正在朝着为促进和监督儿科临床研究而建立拉丁美洲网络的方向发展。
