Document Thérapie 2008 Mars-Avril; 63 (2): 83-88
DOI: 10.2515/therapie:2008023
Good Clinical Practice in Developing Countries: Applying Recommendations
François Bompart1, François Hirsch2, Pierre-Henri Bertoye3 and Muriel Vray41 Direction Accès au Médicament, Sanofi Aventis, Paris, France
2 Institut National de la Santé et de la Recherche Médicale, Paris, France
3 Agence Française de Sécurité Sanitaire des Produits de Santé, département d'inspection des essais cliniques et de sécurité, Paris, France
4 Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France
Text received 19 February 2008 ; accepted 28 April 2008 ; published online 20 June 2008
Abstract - The recommendations for clinical research in developing countries were published in 2007 and the present article deals with issues which were not initially raised or discussed in depth. In particular, we discuss specific questions linked to trials conducted in developing countries with regard to informed consent, research project review by two ethics committees, standards of care, management of biological samples, study follow-up committees, notification of Serious Adverse Events, paediatric trials, and Contract Research Organizations.
Key words: clinical research -- ethics -- developing countries
© Société Française de Pharmacologie et de Thérapeutique 2008