EMA concept paper offers litany of concerns for use of single-arm trials

Hot on the heels of a recent FDA draft guidance on the topic, the EMA last week released a new concept paper which explains the regulator’s many, many concerns with the use of single-arm trials – concerns which any sponsor hoping to leverage a single-arm trial will have to successfully navigate.

Background and Context

Global regulators typically consider blinded, randomized controlled trials (RCTs) to be the gold standard of clinical trials.

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