From now on the organisation – a network of research centres, hospitals, owners of electronic registries and CROs (contract research organisations) intended to improve safety surveillance and risk evaluation across Europe – will publish requests for Phase IV research from third parties, including drugmakers, on its forum.
The idea is that drugmakers seeking to conduct post-approval studies on their pharmaceutical products can detail their specific needs to all 120 ENCePP partners simultaneously rather than approaching them individually.
The ENCePP has also revised its code of conduct with regard to accessing trial data and researchers' declaration of financial interests in a bid to improve the transparency of the post-authorisation research process.
“The revisions to the Code should make it easier for investigators to apply for the ENCePP Study seal as a number of perceived barriers to doing so have now been removed,” said the ENCePP.
It added that the aim is to clarify “the conditions, purpose, suitable approaches as well as limitations for sharing of study data, conditions for data ownership and clarification on the conduct of certain feasibility studies.
“Furthermore, clarification was provided in order to enable the conduct of studies financed from the investigator’s own general resources as well as studies financed from public funding schemes.”
The EMA (European Medicines Agency) – which established the ENCePP in 2007 under its roadmap to 2010 – predicted the changes will increase the number of Phase IV studies the organisation is involved in.
The agency did not respond to Outsourcing-pharma.com’s request for additional information.