PLANNING, REALIZATION AND EVALUATION OF P OST-MARKETING-SURVEILLANCE STUDIES - RECOMMENDATIONS OF THE GESELLSCHAFT-FUR-PHYTOTHERAPIE (GPHY)

Post-marketing-surveillance studies with herbal drugs usually are pros pective prescription-epidemiological studies, which should allow state ments on quality, efficacy and safety. Until now neither laws nor conc rete normative guidelines for the methodology and the evaluation of po st-marketing-surveillance studies are existing which could be used for pharmacovigilance, In the present paper guidelines for planning, real isation and evaluation are presented which should allow studies of hig h quality. The essential components required for the investigational p lan are focused. Also recommendations on the obligatory, optional and special components of the study protocols are made. Additionally stati stical methods which allow the evaluation df the therapeutic efficacy are presented.