ENCePP Public Consultation

ENCePP Code of Conduct for Independence and Transparency
& Checklist of Methodological Research Standards

On 16 November 2009, the European Medicines Agency released for public consultation a draft Code of Conduct for Independence and Transparency, and a draft Checklist of Methodological Research Standards that lay down key elements and principles for the conduct of “European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Studies”.

The objectives of the ENCePP Code of Conduct are to provide a set of rules and principles for Pharmacoepidemiology and Pharmacovigilance studies as regards:

• best practice in the relationship between investigators and study funders, including protocol agreement and publication of results, and
• transparency throughout the research process,
• thereby promoting scientific independence of such studies.

The objectives of the Checklist of Methodological Research Standards are:

• to stimulate researchers  to consider important epidemiological principles when designing a pharmacoepidemiological study and writing a study protocol;
• to promote transparency regarding methodologies and design used in pharmacoepidemiological studies performed in the EU;
• to increase awareness about developments in science and methodology in the field of pharmacoepidemiology.

Background and further Information

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has been created by the European Medicines Agency with a view to bringing together and promoting the use of the available expertise and resources in Europe in the area of Pharmacoepidemiology and Pharmacovigilance. Ultimately, the network’s goal is to both facilitate and improve the conduct of collaborative pharmacoepidemiology and pharmacovigilance studies. A key element of ENCePP is to uphold high standards throughout the research process based on the principles of transparency and scientific independence.

To this end the concept of ‘ENCePP Studies’ is introduced.
In short, all pharmacoepidemiological and pharmacovigilance studies can qualify as an ENCePP study provided that the (primary) lead investigator ¹ belongs to an entity that is included in the ENCePP Inventory of resources ² and that the ‘CoRe requirements’ are met as detailed below.

CoRe requirements Code of Conduct: Signed declaration and checklist Methodological Research Standards: Signed checklist The signed declaration and checklists and the study protocol must be provided to the ENCePP Secretariat before the study commences and will be made publicly available. e-Registry of Post-Authorisation Studies 3 The study should be included in the electronic ENCePP Registry of Post-Authorisation Studies before it commences.

Each document has been developed over a period of several months by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research representing inter alia academia, regulators, patients’ organisations, health care professionals and learned societies. The current draft documents are the result of lengthy and substantive discussions within the Working Groups and beyond, including the ENCePP Implementation Advisory Group (ENCIAG) and the ENCePP Plenary as a whole and take into account acknowledged guidelines and the current state-of-the-art in the area of pharmacoepidemiology and pharmacovigilance.

1 In the context of ENCePP studies, a lead investigator is a person with the scientific background and experience required for the conduct of a particular pharmacoepidemiological or pharmacovigilance study. The lead investigator is responsible for the conduct of a study at a study site. If a study is conducted at several study sites by a team of investigators, the primary lead investigator is the investigator who has overall responsibility for the study across all sites.

2 The Inventory is part of the ENCePP network. The network comprises research centres, University hospitals, owners of healthcare databases and/or electronic registries and existing European networks covering certain rare diseases, therapeutic fields and adverse drug events of interest. Whilst the focus of ENCePP is on public and not-for-profit organisations, for-profit organisations may also qualify for participation in the network provided that they perform studies commissioned by third parties and their main focus is pharmacoepidemiology and pharmacovigilance research. The Inventory is currently under development and is expected to be launched soon at the ENCePP webpage (http://www.encepp.eu).

3 The electronic Registry of Post-Authorisation Studies is currently under development.