GUIDELINES FOR THE IMPLEMENTATION OF DRUG UTILIZATION OBSERVATION (DUO) STUDIES IN PSYCHOPHARMACOLOGICAL THERAPY

The task-force on Phase-IV-Research of the Association for Neuropharma cology and Pharmacopsychiatry (AGNP) has developed guidelines for the implementation of scientifically sound drug utilisation observation st udies (DUG studies). These guidelines have been adopted by the executi ve committee as the position of the association. DUO studies are prosp ective pharmacoepidemiological studies, by which prescription, illness , and patient data of individual patients are collected without interf erence 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 b e used for sales instead of scientific purposes, consultation of an et hics committee is recommended.