FDA reviews the learning from 22 case studies.
Despite what are often reported as promising phase II data, the subsequent failure rate in phase III remains stubbornly high [1,2]. FDA recently took stock of the issue with a review of 22 case studies, ultimately concluding that well designed phase III trials continue to be very important in the drug development and regulatory process as reliance on phase II data alone would likely too often not secure the correct licensing decision. The FDA’s review can be found here.
Fortunately, there are analytical tools and statistical methods that can help the drug developer better judge the strength and predictive ability of their phase II, and other, data versus the likelihood of success of a proposed phase III programme. For further information, insight and expertise, contact KJC Statistics.
- Phase II failures: 2008–2010. Nature Rev. Drug Discov. (2011) 10: 328–329.
- Phase III and submission failures: 2007–2010. Nature Rev. Drug Discov. (2011) 10: 87-88.