Transatlantic Differences in Clinical Testing Requirements - Is There Room for Compromise?
Hendeles L, Byron PR.
RDD Europe 2013. Volume 1, 2013: 111-118.
Abstract:
As a result of differences in requirements for clinical studies between the US and EU drug regulatory agencies, approval has been inconsistent, enormously costly and prolonged. Selection of the comparator arms to be used in studies seems to be the greatest difference and this contributed to the denial of Dulera® in EU but approval in the US, and denial of Flutiform® in the US but approval in EU. Other issues include differences in selection of endpoints and whether including monotherapy with LABA and placebo as comparator arms places subjects at risk. There appears to be room for compromise between the stakeholders with respect to both of these issues as described below.
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