Posted by Michael Wonder on 06 Dec 2016
Failure of investigational drugs in late-stage clinical development and publication of trial results
5 December 2016 - Many investigational drugs fail in late-stage clinical development. A better understanding of why investigational drugs fail can inform clinical practice, regulatory decisions, and future research.
Among 640 novel therapeutics, 344 (54%) failed in clinical development, 230 (36%) were approved by the US FDA, and 66 (10%) were approved in other countries but not by the FDA. Most products failed due to inadequate efficacy (n = 195; 57%), while 59 (17%) failed because of safety concerns and 74 (22%) failed due to commercial reasons.
The pivotal trial results were published in peer-reviewed journals for 138 of the 344 (40%) failed agents. Of 74 trials for agents that failed for commercial reasons, only 6 (8.1%) were published.
