Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications.
Clinical trials conducted before (n=30) and after (n=18) approval had similar design characteristics, such as lack of blinding, randomisation, and comparator groups. Of the required post-approval confirmatory studies, half were completed a minimum of 3 years after approval, and of these, most showed some benefit but relied on surrogate measures rather than clinical outcomes.
