The 100th study has been uploaded in the ENCePP e-register of studies. This register, which was launched by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Medicines Agency in November 2010, provides a free, publicly accessible resource for the registration of post-authorisation studies on medicines. Its purpose is to:
- increase transparency and reduce publication bias;
- promote information exchange and collaboration within the scientific community;
- facilitate the optimal use of relevant expertise by preventing unnecessary duplication of research.
The majority of studies included in the ENCePP e-register are observational studies. These studies play an important role in the safety monitoring of marketed medicines. ENCePP identified the need for a dedicated resource for such studies, because other available registers for studies tend to focus on clinical trials. The registration of the 100th study is a significant milestone in the success of the ENCePP e-register. The e-register includes studies initiated, managed or financed by pharmaceutical companies, as well as those conducted by academic or hospital-based research centres from inside or outside the European Union (EU). Of the 100 studies entered, 50 have been requested by a regulatory authority. The ENCePP e-register of studies also currently serves as the EU PAS register referred to in module VIII of the guideline on good pharmacovigilance practices (GVP) on post-authorisation safety studies (PASSs). A PASS may be requested by regulators to obtain further specific information on a medicine’s safety, or to measure the effectiveness of risk-management measures. As required by the 2010 pharmacovigilance legislation, the protocols and abstracts of results of PASS need to be published.
ENCePP is a network of over 170 research centres, existing networks and providers of healthcare data, which is coordinated by the European Medicines Agency. Its goal is to strengthen post-authorisation monitoring of medicines by facilitating the conduct of multicentre, independent studies focusing on safety and on the balance of benefits and risks, using available European research expertise. As such, ENCePP is seen as a key element in generating robust evidence to support regulatory decision-making for the benefit of public health.
ENCePP has been instrumental in developing the principles and best practice for the conduct of a PASS from inception, contract signature and protocol drafting, through to the reporting of results. This is reflected in the recently published module VIII of GVP on PASSs.