FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Considers Using Big Data and Real-World Evidence in Approval Decisions

March 1, 2017

The EMA identified ways to address the drawbacks of using electronic healthcare records and real-world evidence to support drug development and regulatory decision-making.

Cloud-based systems and machine-learning algorithms, for example, could give drugmakers and the EMA the capacity to store, access and analyze the massive datasets from electronic healthcare records or other real-world sources.

Missing elements and other noise in the data can be overcome through analysis, corroboration, randomized trials and selectivity, according to an EMA report, which follows a big data workshop held late last year.

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