The task-force on Phase-IV-Research of the Association for Neuropharmacology and Pharmacopsychiatry (AGNP) has developed guidelines for the implementation of scientifically sound drug utilisation observation studies (DUO studies).
These guidelines have been adopted by the executive committee as the position of the association.
DUO studies are prospective pharmacoepidemiological studies, by which prescription, illness, and patient data of individual patients are collected without interference with the routine course of treatment.
They can answer questions on the interaction of treatment modalities with positive and negative treatment outcome.
Scientific standards require that there is a study protocol which describes the epidemiological, statistical, procedural, and quality assurance methodology and states who is responsible for what.
As such studies can violate data protection regulations or can be used for sales instead of scientific purposes, consultation of an ethics committee is recommended.
Mots-clés Pascal : Psychopharmacologie, Manuel, Surveillance biologique, Autorisation mise sur marché, Prescription médicale, Ethique, Méthodologie, Homme
Mots-clés Pascal anglais : Psychopharmacology, Manuals, Biological monitoring, Marketing authorization, Medical prescription, Ethics, Methodology, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0120386
Code Inist : 002B02A07. Création : 21/05/1997.