Correlates of time to approval and other clinical development periods.

ABSTRACT

The drug development cycle is classically divided into a clinical phase and review phase, with the clinical phase typically being further partitioned based on the planning and conduct of adequate and well controlled trials. Factors affecting the duration of the development intervals have not previously been systematically investigated. Here, we analyze a large population (N=825) of New Drug Applications (NDAs) approved between 2008 and 2017 to characterize the typical duration of these intervals and the development factors associated with their duration. These data and analyses will help those involved in pharmaceutical development by enabling data-driven planning and by providing insight into the effect of certain factors on the duration of drug development programs.