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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Sullivan L. Defining “quality that matters” in clinical trial study startup activities. Monitor. 2011;25:22–26.
Li G, Harper B, Sirabella L. Activating investigative sites in a staggered process: challenges and solutions. In: Parexel Biopharmaceutical R&D Statistical Sourcebook 2011/2012. Waltham, MA; PAREXEL International Corp; 2011:175–177.
Manak D, Chung J, Reuter S. Study startup 2.0: reinventing how clinical trials begin. Monitor. 2011;25:33–38.
Panzitta D. Avoiding the 5 common mistakes at study startup. Available at: http://www.appliedclinicaltrialsonline.com. Accessed July 27, 2010.
Korieth K. Budding relationships. In: European Pharmaceutical Contractor. London, UK; Samedan Ltd Publishers; 2011:10–14.
Lamberti M, Zuckerman R, Howe D, Shapiro L, Getz K. Factors influencing site willingness and ability to participate in clinical trials. Drug Information Journal. 2011;45:3:377–390.
Korieth K, Anderson A. Sites rate NovoNordisk, Roche, Amgen on top. CenterWatch. June 2011.
Kroll J ed. An Industry in Evolution. 2nd ed. Boston:CenterWatch Publications; 1999:175–176.
Taylor N. Latin American sites recruit 91% more patients than US. Available at: http://www.outsourcing-pharma.com. Accessed November 23, 2010.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Lamberti, M.J., Brothers, C., Manak, D. et al. Benchmarking the Study Initiation Process. Ther Innov Regul Sci 47, 101–109 (2013). https://doi.org/10.1177/2168479012469947
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479012469947