www.fdanews.com/articles/180684-ema-considers-using-big-data-and-real-world-evidence-in-approval-decisions
EMA Considers Using Big Data and Real-World Evidence in Approval Decisions
February 28, 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.