Good clinical practice in developing countries: applying recommendations.
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.
Bompart
François
F
Direction Accès au Médicament, Sanofi Aventis, Paris, France. francois.bompart@sanofi-aventis.com
Hirsch
François
F
Bertoye
Pierre-Henri
PH
Vray
Muriel
M
D000328:Adult; D002648:Child; D003695:Delivery of Health Care / Q000941:ethics / Q000592:standards*; D003906:Developing Countries; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007258:Informed Consent; D010372:Pediatrics; D012106:Research; D013048:Specimen Handling