Research report

'START' (Start-up Time And Readiness Tracking) Study

Tufts CSDD Research Report 2012: 'START' (Start-up Time And Readiness Tracking) Study

Benchmarking the Study Initiation Process

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.

The research was funded by goBalto, the industry leader in study startup.

Ken Getz
KEN GETZ
Director of Sponsored Research Programs & Associate Professor
Tufts Center for the Study of Drug Development
"The study start-up phase is highly inefficient and rich with opportunity for improvement. The results of the START study summarized in the manuscript offer important insights into areas of leverage in improving study initiation speed and efficiency."

About Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group at Tufts University in Boston, Massachusetts. Our mission is to develop strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical and biopharmaceutical development, review, and utilization. Our path-breaking research informs the research-based industry, regulatory agencies, and the public about the nature and pace of pharmaceutical development.

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