EMA releases guidance on using pharmacogenetics in clinical trials

Guidance aims to increase the usefulness of the information gathered from genomic studies and help integrate pharmacogenomics into drug development and patient treatment

The European Medicines Agency (EMA) has developed guidance on using genomic biomarkers in clinical trials and other studies, advising on the choice of pharmacogenetics technology.

This work, said EMA’s advice 'should follow certain principles in order to generate reliable evidence for decision making and patient treatment'.

The guidelines build on earlier International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and EMA’s own advice outlining principles for the regulatory evaluation of genomic biomarkers. However, said EMA: 'There is currently no guideline on good genomic practices.'

The intention of this latest guidance is to increase the usefulness of the information gathered from genomic studies and help integrate pharmacogenomics into drug development and patient treatment.

Looking at the critical stage of clinical trials design, EMA said genomic variation has to be considered and is 'of critical importance for a successful outcome' of such studies.

Moreover, the clinical validation of genomic biomarkers is important to confirm associations with functional phenotypes important for clinical pharmacokinetics, efficacy or safety: 'Good pharmacogenomic practice will impose certain requirements to the study design that are necessary to allow the validation of genomic biomarkers for clinical use or for drug development.'

Chosen biomaterials need to be appropriate for a study’s objective and diagnostic tissue quality should be maximised while inter-sample differences in quality are minimised.

The guidance also advises on epigenetic alterations; rare mutations in drug response; sample preparation and methods for mutation evaluation; vivo study design, including randomised controlled trials; pharmacogenomic drug labels; and more.

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