June 13, 2019

Pharma R&D failure and success (2)

Estimation of clinical trial success rates and related parameters

The largest investigation thus far into clinical trial success rates and related parameters sheds light on the issue.
We find that the overall success rate for all drug development programs did decrease between 2005 (11.2%) and 2013 (5.2%), as anecdotal reports suggest. However, this decline reversed after 2013. The overall success rate is mainly driven by changes in POS1,2 and POS2,3. The timing of the upward trend coincides with the time period during which the FDA has been approving more novel drugs,compared to the historical mean.
Quite surprising. The accelerated approval by FDA ends with more drugs withdrawn from the market. Therefore, the probability of success is a flawed statistic. It should be adjusted according to regulator criteria.