Arzneimittelforschung. 1997 Aug; 47(8): 990-4.

[Planning, realization and evaluation of post-marketing surveillance studies. Recommendations of the Society for Phytotherapy]

Kraft K, Loew D, Schneider B, Kemper FH.

Arbeitsgruppe Anwendungsbeobachtungen der Gesellschaft f�r Phytotherapie, KÃ¶ln.

Post-marketing-surveillance studies with herbal drugs usually are prospective prescription-epidemiological studies, which should allow statements on quality, efficacy and safety. Until now neither laws nor concrete normative guidelines for the methodology and the evaluation of post-marketing-surveillance studies are existing which could be used for pharmacovigilance. In the present paper guidelines for planning, realisation and evaluation are presented which should allow studies of high quality. The essential components required for the investigational plan are focussed. Also recommendations on the obligatory, optional and special components of the study protocols are made. Additionally statistical methods which allow the evaluation of the therapeutic efficacy are presented.