Tufts CSDD START Research Report

Tufts CSDD START II Research Report
The study startup phase of a trial is an area that pharmaceutical and biotechnology companies are focusing on in order to reduce delays and improve efficiency. To better understand and examine metrics within study startup, the Tufts Center for the Study of Drug Development (CSDD), in collaboration with 11 pharmaceutical and biotechnology companies, examined a comprehensive set of metrics and analyzed study data from 105 global clinical trials. The results indicate that the early stages of the site initiation process are areas that accounted for the majority of cycle time. An examination of cycle time to the first patient in by therapeutic area also reveals variation. Variations in cycle time to the first patient occur by site type as well as by region. Academic institutions and government-funded sites were longest to the first patient in, while physician practices were fastest.

Areas examined in the research include:

  • Sponsor and CRO practices with regards to study initiation cycle times in order to establish industry benchmarks.
  • Challenges and perceptions associated with the study initiation process.
  • Organizational resources or process changes which could speed study initiation.
  • The identification and quantification of industry trends in the study initiation process.