14 August 2014
The European Medicines Agency (EMA) has opened a consultation on new draft guidance on good practice in the use of genomic biomarkers.
The EMA is responsible for the scientific evaluation of medicines intended for use within the European Union (EU). Their new concept paper is intended to recognise ‘the importance of genomics in the development of innovative, targeted treatments’ by establishing a framework for the generation and evaluation of ‘robust genomic data’.
The increasing importance of genomic data for proper evaluation of the benefits and risks of a potential new drug is recognised; pharmacogenetic variation between individuals means that a medicine may be more effective (or more dangerous) in genetically defined sub-populations at a given dosage. Biomarkers may also be used for diagnosis or in monitoring of treatment responses.
The EMA paper says that clinical translation of emerging knowledge about genomic biomarkers of health and disease currently lags behind the science, partly due to a lack of consistent good practice in trial design. They are calling for stakeholder input on genomic technologies, methods and data, as well as on key issues involved in the translation of such genomic data into clinical practice.
The consultation period closes at the start of November 2014.