Good Clinical Practice in Developing Countries: Applying Recommendations

¹ 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

Received: 19 February 2008
Accepted: 28 April 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.