Benchmarking the Study Initiation Process

Therapeutic Innovation & Regulatory Science
Mary Jo LambertiKen Getz

Abstract

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.

Citations

May 17, 2018·Oncotarget·Eric D SlosbergAugust Salvado
Aug 8, 2015·Nature·Trudie Lang
Mar 27, 2015·Clinical Pharmacology and Therapeutics·B P KangA Salvado
May 2, 2018·Therapeutic Innovation & Regulatory Science·Mary Jo LambertiKen Getz
Nov 15, 2017·Future Science OA·Brianna M KrafcikMarina A Malikova
Jan 31, 2020·Trials·Amani Abu-ShaheenMohamad Al-Tannir
Mar 4, 2021·Clinical Trials : Journal of the Society for Clinical Trials·Henshaw MandiGunnstein Norheim

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