Guidelines for Clinical Research in Developing Countries

¹ Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France
² Service de Microbiologie, CHU Saint-Louis, Paris, France
³ Direction Accès au Médicament, Sanofi-Aventis, Paris, France

Abstract

On the basis of a review of current clinical research conditions in developing countries, guidelines have been formulated to ensure scientific validity as well as adherence to universal ethical principles. The main recommendation is that projects should be reviewed by two Institutional Review Boards, one in the country where the Study Sponsor is based, and another in the country where the study is being carried out. In addition, an independent Data Safety Monitoring Board should be set up and systems established to ensure the effective reporting of Serious Adverse Events and to specify the Sponsor's obligations after the end of the Study.