EU Pharmacovigilance Network launches pharmacogenetics advice
Adds guidance on the design and analysis of pharmacogenetic studies
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has revised its guide on methodological standards in pharmacoepidemiology, adding a chapter on the design and analysis of pharmacogenetic studies. These investigate how individual genetic variations determine a patient’s response to a medicine, therapeutically and regarding side effects.
The new chapter '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,' said the ENCePP.
It also contains weblinks to internationally agreed recommendations and key guidelines, published articles and textbooks, highlighting good practice.
The ENCePP links more than 170 research centres with healthcare data holders, trying to boost the post-authorisation monitoring of medicines.
'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,' the network said.