Pharmaceutical Development Phases: A Duration Analysis

This paper estimates a duration model of late stage drug development in the pharmaceutical industry using publicly available data. The paper presents descriptive results on the estimated relationship between a particular drug's characteristics such as therapy category, route of administration and originator's size, and that drug's pathway through the three stages of human clinical trials and regulatory review. The results suggest that drugs with longer durations are less likely to succeed, drugs from larger firms are more likely to succeed and faster in the later phases of development, and that durations fell between 1995 and 2002.