Good clinical practice in developing countries: applying recommendations

François Bompart; François Hirsch; Pierre-Henri Bertoye; Muriel Vray; participants in Round Table No1, Giens XXIII

doi:10.2515/therapie:2008022

Good clinical practice in developing countries: applying recommendations

Therapie. 2008 Mar-Apr;63(2):83-8, 77-82. doi: 10.2515/therapie:2008022. Epub 2008 Jun 20.

[Article in English, French]

Authors

François Bompart¹, François Hirsch, Pierre-Henri Bertoye, Muriel Vray; participants in Round Table No1, Giens XXIII

Collaborators

participants in Round Table No1, Giens XXIII:
Brigitte Bazin, Jean-François Chambon, Philippe Deloron, Michel Garenne, Martha Gersberg, Philippe Guérin, Yves Juillet, Valérie Lameyre, Annie Leblond, Mohamed L'Hadj, Rafaella Ravinetto, Gilles Riveau, Anne-Marie Schacht, François Simon, Christine Toneatti, Els Torreele, Philippe Urfalino

Affiliation

¹ Direction Accès au Médicament, Sanofi Aventis, Paris, France. [email protected]

PMID: 18561879
DOI: 10.2515/therapie:2008022

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.

Publication types

Review

MeSH terms

Adult
Child
Delivery of Health Care / ethics
Delivery of Health Care / standards*
Developing Countries*
Drug-Related Side Effects and Adverse Reactions
Humans
Informed Consent
Pediatrics
Research
Specimen Handling