The EMA has launched a consultation on the circumstances in which single-arm trials (SATs) – those without a control group – can be used to support marketing applications
Despite randomised clinical trials (RCTs) being the gold standard for drug approval studies, the shift towards precision medicine has increased the use of single-arm trials (SATs).
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh