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www.fdanews.com/articles/177375-ema-says-drug-sponsors-have-trouble-with-real-world-data-adaptive-trials
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EMA Says Drug Sponsors Have Trouble With Real-World Data, Adaptive Trials

July 6, 2016

When given the opportunity to use real-world data and adaptive trial designs to secure marketing authorization, drug sponsors often struggle to develop innovative approaches.

EMA Senior Medical Officer Hans-Georg Eichler explained that the agency launched an adaptive pathways pilot project in March 2014 that allowed drug sponsors to supplement clinical trial data for drug approvals with real-life evidence. However, participants have struggled to incorporate real-world data and devise novel trial designs incorporating it, Eichler said.

Eichler’s comments come on the heels of a report from the Bipartisan Policy Center pressing the FDA to develop guidance documents on the use of real-world data. The report says that with the advent of personalized medicine targeting smaller patient populations, the randomized clinical trials that the agency relies on for drug approvals are becoming “increasingly less relevant.”

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