Europe builds trust in risk/benefit studies

A new form of study for assessing the benefits and risks of medicines has been launched in the EU with the hope of increasing public trust in study findings. Investigators who choose to conduct the new type of study commit to a “maximum level of transparency”, according to a statement from the European Medicines Agency (EMA), which includes the publication of all study findings — whether positive or negative. Relevant information will also be entered into a publicly available electronic register (currently being developed by the EMA) before the study commences.

The initiative is being led by the EMA and the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP). The studies will be called ‘ENCePP studies’ and will act as a seal that the EMA hopes will “increase trust in the robustness of findings”.

ENCePP benefit/risk or risk studies will be performed in compliance with the ENCePP’s code of conduct, which is designed to ensure transparency and promote scientific independence. The code lays down rights and obligations between investigators and study funders, and covers aspects such as the development of the study protocol, the conduct of the study and data ownership, as well as access to data and publication of the results.