Posted by Michael Wonder on 11 Sep 2019
The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation and accelerated assessment, speed up EMA marketing authorisation recommendations for medicinal products.
Bruce et al. used European Public Assessment Reports (EPARs) to identify the primary endpoints in the pivotal trials supporting products authorised through conditional marketing authorisation or accelerated assessment pathways during January 1, 2011 to December 31, 2018.
They excluded products that were vaccines, topical, reversal, or bleeding prophylactic agents or withdrawn within the study time frame.
