We are happy to announce that TEDDY is a registered network at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP, www.encepp.eu) since September 2015. ENCePP is an initiative coordinated by the European Medicines Agency (EMA) with the aim of strengthening post-authorisation research, pharmacoepidemiological research and risk-benefit monitoring of medicines.
All ENCePP activities will be followed by TEDDY through its delegates, Sebastian Botzenhardt from Universitätsklinikum Erlangen (UKER), and Mariagrazia Felisi from Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF). TEDDY first engagement with the network has been the participation in the 14th ENCePP Plenary Meeting held at the EMA in London on 24th November 2015.
What is ENCePP relevance in the field of clinical research?
The ENCePP network provides a contact point for researchers from industry, academia and regulatory authorities interested in collaborations in the conduct of post-authorisation studies (PAS). Currently, it entails 155 centres, 24 networks and 53 data sources, and is constantly growing.
Moreover, ENCePP offers a study registry (EU PAS Register) for all pharmacovigilance and pharmacoepidemiology studies, especially post-authorisation safety studies (PASS). The registry aims to provide non-interventional studies a similar transparency platform as for clinical trials.
What is the current status of EU PAS Register?
In December 2015, 679 studies have been registered in the EU PAS Register. As positive aspect, ENCePP increased their registered studies from about 400 (11/2014) to 660 (11/2015). Unfortunately, this is still disappointing, also having in mind that roughly 10% of clinicaltrials.gov’s studies are non-interventional (~20,000). For this reason, the meeting was an occasion to promote registering studies of ENCePP partners and to promote the EU PAS Register in the scientific community. Unfortunately, at the moment it is not mandatory to register these studies and thus it is difficult to determine how many studies are currently missing in the registry.
Does ENCePP provide rules for PAS?
ENCePP develops a guide for conducting post-authorisation studies, without being in conflicts with other similar documents. ENCePP guidance will foresee specific sections for drug research in pregnancy and in children. It has been also discussed the possibility to publish a summary of these guidelines in a scientific journal allowing better citation and distribution.
Do you consider feasible an ENCePP action for a better exploitation of already existing data?
ENCePP could facilitate EMA’s initiative for patient registries promotes a better use of existing data on drug safety and efficacy. In fact, it could provide expertise in the identification and evaluation of existing data sources. During the meeting it was clarified that many cohort studies are wrongly described as registries. However, the key difference is that registries are always exhaustive whereas cohort study include only a fraction of a population.
All the ENCePP meeting outcomes are available in the official report, that also includes key point of the discussion on the topic of funding for PAS studies. Further details will be periodically published on the TEDDY website.