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.
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Acknowledgements
The authors are very grateful to SIBEN for its help in disseminating the survey, and to the professionals and institutions (listed below) that completed the survey. None of the authors received funding for this work and all declared no conflicts of interest.
Argentina: Hospital Regional Rios Gallegos, Rios Gallegos; Hospital Dr Alberto Duhau Jose CPaz, Buenos Aires; Hospital Privado de Comunidad, Mar del Plata (Dr Diego Natta); Hospital Italiano de La Plata, Mar del Plata (Dr Guillermo Agustin Zambosco); Hospital de Pediatría J.P. Garrahan, Buenos Aires.
Brazil: Paediatric Department, Hospital Universitario Walter Cantidio, Universidad Federal do Ceara, Fortaleza (Dr Christiane Leite); Infectious Diseases Department, Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo (Dr Heloísa Helena de Sousa Marques); Fundação Oswaldo Cruz, Rio de Janeiro (Dr Maria Elisabeth Lopes Moreira)
Colombia: Hospital Universitario de Santander, Universidad Industrial de Santander, Bucaramanga; Clinica del Country, Bogotá (Dr Angela Hoyos); Clinica Universitaria Bolivariana, Medellín (Dr Andres Felipe Uribe Murillo); Clinica General del Norte, Santa Fe (Dr Ricardo Sanchez Consuegra); Centro Policlínico del Olaya, Salud Total EPS-S, Bogotá (Dr Catherine Rojas Cardenas)
Cuba: Hospital Provincial Docente Ginecobstetrico, Matanzas.
El Salvador: Hospital de Niños Benjamín Bloom, San Salvador (Dr Tania Lizeth Arèvalo Saade); Hospital Nacional de Maternidad “Dr. Raúl Argüello Escolán”, San Salvador (Dr Mario Hernany Callejas Castro); Hospital Nacional San Rafael, Santa Tecla (Dr Edelio Eduardo Mejìa Guardado)
Guyana: Georgetown Public Hospital; St Joseph’s Mercy Hospital, Georgetown. Special thanks to Dermot Preston SJ and Sister Querida Hume-Wright (Jesuit Missions) for coordinating the distribution and completion of questionnaires by the main pediatricians in Guyana.
Mexico: Hospital Central Dr Ignacio Morones Prieto, Universidad Autonoma de San Luis, Potosi; Hospital Centenario Miguel Hidalgo, Aguascalientes; Instituto de Salud del Estado de Mexico, Mexico City; Paediatric Hospital, “Centro Medico Nacional Siglo XXI”, Instituto Mexicano del Seguro Social, Mexico City; Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Merida, Yucatan (Dr David Sanchez); Centro Medico Nacional 20 de Noviembre ISSTE, Ciudad de Mexico; Instituto Nacional de Pediatría, Ciudad de Mexico. Special thanks to Dr Carlos Agustín González Lozano for coordinating the response of 20 pediatricians and pharmacists from his institution.
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Arenas-López, S., Fajardo, C., Valls i Soler, A. et al. Pediatric Clinical Trials in Latin America and Guyana. Pediatr-Drugs 13, 257–265 (2011). https://doi.org/10.2165/11590350-000000000-00000
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DOI: https://doi.org/10.2165/11590350-000000000-00000