To undertake the feasibility of establishing a case-cohort surveillance network (Euronet), based on representative regions of the European Union (EU), to monitor the safety of new active substances particularly those marketed under the Centralised & Decentralised Procedures.
To undertake a trans-European case-control study of acute pancreatitis.
To develop and improve methods for pharmacovigilance including spontaneous reporting systems (SRSs), meta-analyses and mechanistic approaches.
The Euronet project will be undertaken in two parts. First, a retrospective model, using data on gastrointestinal haemorrhage and serious blood dyscrasias recently obtained by members of the EPRG as part of a case-control study, will be re-analysed using a case-cohort approach. This will allow risk estimates from the two methods to be compared. Second, a feasibility study will be undertaken in 3 EU regions (Bordeaux, Birmingham and Stockholm) to capture, prospectively, cases of up to 4 conditions associated with serious adverse drug reactions. Simultaneously relevant drug consumption data, for each of the regions, will be acquired particularly for those products granted marketing authorisation under the EC Centralised & Decentralised procedures. Results will be compared with those obtained from SRSs.
The case-control study of drug aetiological factors in acute pancreatitis will involve the identification of 900 cases and l 800 controls across 6 member states (Denmark, Italy, Netherlands, Portugal, Sweden and the United Kingdom. This will permit reliable estimates to be made of the relative risks associated with important therapeutic classes.
Pharmacovigilance methodological research will encompass approaches for improving the promotion, collection and analysis of SRSs; further critical examination of the use of meta-analytical techniques in the overview of observational studies; and the establishment of a tissue bank for the storage of material for patients with serious ADRs.
Funding SchemeCSC - Cost-sharing contracts
3000 RN Rotterdam
5000 Odense C
B15 2TT Birmingham