Guidelines for the Implementation of Drug Utilization Observation (DUO) Studies in Psychopharmacological Therapy

M. Linden; D. Baier; H. Beitinger; R. Kohnen; M. Osterheider; M. Philipp; D. E. Reimitz; B. Schaaf; H. J. Weber

doi:10.1055/s-2007-979520

Pharmacopsychiatry 1997; 30: 65-70
DOI: 10.1055/s-2007-979520

Original Paper

Guidelines for the Implementation of Drug Utilization Observation (DUO) Studies in Psychopharmacological Therapy

The "Phase IV Research" Task-Force of the Association for Neuropsychopharmacoiogy and Pharmacopsychiatry (AGNP):M. Linden¹ , D. Baier² , H. Beitinger³ , R. Kohnen⁴ , M. Osterheider⁵ , M. Philipp⁶ , D. E. Reimitz⁷ , B. Schaaf⁸ , H. J. Weber⁹

¹Department of Psychiatry, Free University of Berlin, Germany;
²Hoffmann-La Roche, Grenzach-Wyhlen, Germany;
³Arzneimittelwerk Dresden, Dresden, Germany;
⁴IMEREM, Nürnberg, Germany;
⁵Department of Psychiatry, University of Würzburg, Germany;
⁶BKH Landshut, Germany;
⁷Thiemann, Wintrop, Germany;
⁸FACTUM, Offenbach, Germany;
⁹Lilly, Bad Homburg, Germany

Abstract

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Abstract

The task-force on Phase-IV-Research of the Association for Neuropharmacology and Pharmacopsychiatry (ACNP) 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.

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