July 17, 2018, Vol 320, No. 3, Pages 215-316
Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
Jeremy Puthumana, MS; Joshua D. Wallach, PhD, MS; Joseph S. Ross, MD, MHS
JAMA. 2018;320(3):301-303. doi:10.1001/jama.2018.7619
This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approvals.