| Autor: |
Bompart F; Direction Accès au Médicament, Sanofi Aventis, Paris, France. francois.bompart@sanofi-aventis.com, Hirsch F, Bertoye PH, Vray M |
| Jazyk: |
English; French |
| Zdroj: |
Therapie [Therapie] 2008 Mar-Apr; Vol. 63 (2), pp. 83-8, 77-82. Date of Electronic Publication: 2008 Jun 20. |
| DOI: |
10.2515/therapie:2008022 |
| Abstrakt: |
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. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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