The agency is taking a look at better use of genomic data and biomarkers in medicines development and safety monitoring.
The European Medicines Agency has released a draft concept paper for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices. The concept paper proposes a framework for the generation and assessment of robust genomic data.
The outcome of the consultation will according to the agency inform the future guideline, which will aim to set out the key principles underpinning the generation of robust clinical genomic datasets throughout a medicine’s lifecycle. This includes the rationale for using genetic investigation, the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the appropriate level of analysis and reporting of genomic data. Furthermore, the guidance would also highlight key scientific aspects of the translation of the available genomic data into clinical practice.
With the guidance the EMA aims to enhance transparency, consistency, reproducibility and cross-validation between genomic-driven studies. This is expected to promote and facilitate the use of genomic data for the development of personalised medicines, the safety monitoring of medicines and the early diagnosis of disease.