EMA Outlines Best Practices for Improving Drug Development Research

May 6, 2016

The EMA is spelling out how companies can use genomic data to improve drug development research.

As the pharmaceutical industry moves toward a genomic basis for individualized treatments, an EMA draft guidance has identified a slew of pitfalls companies can avoid by properly employing pharmacogenomics.

The agency pointed toward the “poor quality of employed analytics” as one of the foremost drawbacks of misusing pharmacogenomics in trial design, along with the lack of appropriate phenotype identification and inadequate patient selection. While previous pharmacogenomics guidances have focused on issues such as clinical development and risk management, this document concentrates on analysis and applying that to best practices.


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