4.0 Article

Benchmarking the Study Initiation Process

Journal

THERAPEUTIC INNOVATION & REGULATORY SCIENCE
Volume 47, Issue 1, Pages 101-109

Publisher

SAGE PUBLICATIONS INC
DOI: 10.1177/2168479012469947

Keywords

study start-up; site initiation; cycle time

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The study start-up 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 start-up, the Tufts Center for the Study of Drug Development, 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.

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