Post-authorization efficacy studies

Enhancing understanding of therapeutic efficacy under real-use conditions

Post Authorization Efficacy studies (PAES) are increasingly imposed by the European Medicines Agency (EMA) on the market authorization. PAES data are used to complement available efficacy data when there are scientific uncertainties over aspects of a medicine’s efficacy when used within its therapeutic indication. These uncertainties usually concern benefits within a specific sub-population, which may not have been included in pre-market development (e.g. renal insufficiency or pediatric populations). They may also relate to concerns over the long-term benefit, or in the case of vaccines, on the potential impact of herd immunity on efficacy.

ZEG Berlin’s study methodology naturally lends itself to PAES. The collection of primary data within the outpatient clinical environment has been successfully used by ZEG Berlin to conduct efficacy studies in the past. Our EURAS/INAS studies include efficacy outcomes as part of the study design providing real-life data under routine clinical use.