Literature DB >> 21692549

Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future.

Sara Arenas-López1, Carlos Fajardo, Adolf Valls i Soler, Jorge Raúl García-Corzo, Ma Victoria Lima-Rogel, Graciela Calle, Roberio Leite, Edgard Lobos, Querida Hume-Wright, Stuart MacLeod.   

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.

Entities:  

Mesh:

Year:  2011        PMID: 21692549     DOI: 10.2165/11590350-000000000-00000

Source DB:  PubMed          Journal:  Paediatr Drugs        ISSN: 1174-5878            Impact factor:   3.022


  9 in total

1.  Globalized pediatric research.

Authors:  Samuel Maldonado; Jesse Berlin; Jay Siegel; Joanne Waldstreicher
Journal:  Pediatrics       Date:  2011-01       Impact factor: 7.124

2.  The infancy of an international pediatric pharmacy network.

Authors:  David Knoppert; Sara Arenas-Lopez; Rowena McArtney
Journal:  Paediatr Drugs       Date:  2008       Impact factor: 3.022

3.  Challenges in international pediatric pharmacology: a milestone meeting in Shanghai.

Authors:  Stuart MacLeod; Robert Peterson; Yi Wang; Zhiping Li; Yonghao Gui; Jane Schaller
Journal:  Paediatr Drugs       Date:  2007       Impact factor: 3.022

4.  Pediatric Pharmacy Advocacy Group International Pediatric Pharmacy and Pharmacology Symposium, 24-26 April 2009; Orlando, Florida, USA.

Authors:  Michelle I Wilde
Journal:  Paediatr Drugs       Date:  2009       Impact factor: 3.022

5.  Published pediatric randomized drug trials in developing countries, 1996-2002.

Authors:  Khairun N B Nor Aripin; Helen M Sammons; Imti Choonara
Journal:  Paediatr Drugs       Date:  2010-04-01       Impact factor: 3.022

6.  Detection of Leishmania braziliensis DNA in American tegumentary leishmaniasis patients.

Authors:  Leila Martins; Aline Alexandrino; Georgia Guimarães
Journal:  Rev Saude Publica       Date:  2010-04-30       Impact factor: 2.106

7.  Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity.

Authors:  Sara K Pasquali; Danielle S Burstein; Daniel K Benjamin; P Brian Smith; Jennifer S Li
Journal:  Pediatrics       Date:  2010-08-23       Impact factor: 7.124

8.  StaR Child Health: an initiative for RCTs in children.

Authors:  Terry P Klassen; Lisa Hartling; Michele Hamm; Johanna H van der Lee; Jennie Ursum; Martin Offringa
Journal:  Lancet       Date:  2009-10-17       Impact factor: 79.321

9.  The globalization of pediatric trials: should we be worried?

Authors:  Julia Dunne; Dianne Murphy; Gerold Wharton
Journal:  Pediatrics       Date:  2011-01       Impact factor: 7.124

  9 in total
  4 in total

1.  A quarter century of progress in paediatric clinical pharmacology: A personal view.

Authors:  Stuart M MacLeod
Journal:  Br J Clin Pharmacol       Date:  2015-11-10       Impact factor: 4.335

2.  Engagement of the community, traditional leaders, and public health system in the design and implementation of a large community-based, cluster-randomized trial of umbilical cord care in Zambia.

Authors:  Davidson H Hamer; Julie M Herlihy; Kebby Musokotwane; Bowen Banda; Chipo Mpamba; Boyd Mwangelwa; Portipher Pilingana; Donald M Thea; Jonathon L Simon; Kojo Yeboah-Antwi; Caroline Grogan; Katherine E A Semrau
Journal:  Am J Trop Med Hyg       Date:  2015-02-02       Impact factor: 2.345

Review 3.  Impact, challenges, and future projections of vaccine trials in Africa.

Authors:  Olubukola T Idoko; Sonali Kochhar; Tsiri E Agbenyega; Bernhards Ogutu; Martin O C Ota
Journal:  Am J Trop Med Hyg       Date:  2013-03       Impact factor: 2.345

4.  Pediatric clinical trials.

Authors:  Sandeep B Bavdekar
Journal:  Perspect Clin Res       Date:  2013-01
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.