Posted by Michael Wonder on 05 Jun 2018
Postmarket studies required by the US FDA for new drugs and biologics approved between 2009 and 2012: cross-sectional analysis
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one post-marketing requirement at the time of first approval, for a total of 437 post-marketing requirements.
Post-market study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) post-marketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies.
Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomisation, comparator type, allocation, outcome, and number of patients to be enrolled, respectively.
