EMA: Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has revised its guide on methodological standards in pharmacoepidemiology and added a chapter on the design and analysis of pharmacogenetic studies.
These studies aim to investigate how individual genetic variations determine the response to a medicine, both in terms of therapeutic effect and adverse drug reactions. They help optimise the prediction of treatment response leading to a better use of medicines.
The new chapter on pharmacogenetic studies provides a comprehensive overview of all relevant methodological guidance for the conduct of pharmacogenetic studies, from the identification of genetic variants through to study design, data collection, analysis and reporting.
Like the other sections of the guide, this chapter contains web links to internationally agreed recommendations and key points from important guidelines, published articles and textbooks. It also highlights good practice guidance for the conduct of these studies.
ENCePP is a network of over 170 research centres, existing networks and providers of healthcare data, whose aim is to strengthen the post-authorisation monitoring of medicines by facilitating the conduct of multicentre, independent and scientifically robust studies focusing on the safety and balance of benefits and risks.
By offering a single and comprehensive overview of all relevant methodological guidance for researchers in pharmacoepidemiology and pharmacovigilance, the ENCePP guide is a key tool in supporting high quality post-authorisation studies.
Users can view the guide as HMTL webpages with links to each chapter and section and also as a consolidated PDF version for download.
The guide is updated annually to ensure that all developments in the field are incorporated.
Posted on the EMA website on 14 July 2014