top of page

Do Strict Decision Criteria Hamper Productivity in the Pharmaceutical Industry?

An article by Captario Head of Science, Stig Johan Wiklund, published in the Journal of Biopharmaceutical Statistics.


The discouragingly high rates of attrition in drug development, and in particular in Phase 2, warrant a closer look at the decision criteria applied for investment in the next phase (Phase 3). We have in this article evaluated Stop/Go criteria after Phase 2, based on a model encompassing both Phase 2 and 3, as well as the eventual outcome on the market. The results indicate that the value of a drug project is often maximized if rather liberal decision criteria are applied. The routine adherence to standard criteria, e.g. requiring significance at 5% level, may lead to an unduly high rate of false negative decisions. This might ultimately hamper the productivity of drug development and leading to potentially useful drugs not being taken forward to benefit the intended patients.

Do strict decision criteria hamper productivity in the pharmaceutical industry_ _ Stig-Joh
Download • 8.82MB


bottom of page