Numéro |
Thérapie
Volume 63, Numéro 2, Mars-Avril 2008
|
|
---|---|---|
Page(s) | 83 - 88 | |
Section | Bonnes pratiques cliniques/Good Clinical Practices | |
DOI | https://doi.org/10.2515/therapie:2008023 | |
Publié en ligne | 20 juin 2008 |
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
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