Pediatric Clinical Trials in Latin America and Guyana: Present Views of Local Practitioners and Ways to Embrace the Future

Author： Arenas-López Sara

Publisher： Adis International

ISSN： 1174-5878

Source： Pediatric Drugs, Vol.13, Iss.4, 2011-08, pp. : 257-265

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Abstract

Background 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.Objective and Methods 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).Results 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.Conclusion 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.