Post-authorisation study

Post-authorisation studies (PASS and PAES)

At the time of authorisation, there is evidence from clinical trials which demonstrates efficacy, but only for a specific indication and only within the original test population, and there is evidence of adverse reactions, but only the most common ones. In order to create a complete picture of the efficacy and safety of a drug in a real world setting, the authorities may request a post-authorisation efficacy study (PAES). These studies are requested or performed on a voluntary basis when additional information on the efficacy of your drug can only be determined after granting market authorisation or when previous efficacy evaluations should be revised. One of the main reasons for performing a PAES is to address uncertainties concerning subpopulations. Through our extensive Database Network we can easily identify relevant subgroups and stratify the efficacy results by subpopulation, which will give you insight into the effect of these characteristics on the efficacy of your therapy.

Besides additional efficacy data, there may also be a need for additional data on the safety of your treatment in a real life setting (PASS). Through the linkage of multiple databases, we can monitor whether patients using a certain drug have an increased risk of complications. Some of these complications may be diagnosed at the GP, but for the more severe complications you would need data from the hospital. Depending on your specific research question we will link the most relevant databases and will be able to monitor all safety issues in your patient population. Click here for more information on our data.