Tufts CSDD START II Mini-Report: Centralized vs. Non-Dedicated (localized) Functional Groups
Challenges Remain in Study Startup
Tufts Center for the Study of Drug Development (CSDD) conducted an in-depth study on the clinical trial start-up process of biopharmaceutical and CRO companies in order to gather robust, quantitative insights into the selection process as a follow-up to the ground breaking 'START' (Start-up Time And Readiness Tracking) Study completed in 2012.
The new study, START II, focused on the end-to-end process of site identification through site initiation, on the challenges organizations are facing, and on new tools, technologies, and approaches being developed to overcome those challenges. The survey found wide variation between companies, indicating that company practices are highly inconsistent.
The study comprises data from 600 respondents from over 400 unique companies, 54% pharma and biotech 24% CROs with ~80% of respondents having more than 6 years in clinical development/clinical operations.
Areas examined in the survey include:
- Site selection practices and decision-making, study start up, and site feasibility
- Implementation of specific tools and resources that impact cycle time, cost, and performance.
- Factors contributing to poor site selection; improvements made to the site selection and start up processes.
- Key performance metrics (e.g., cycle time) were gathered.
Several mini-reports were produced from the comprehensive START II research report, including this one, focusing on areas of particular interest for stakeholders requiring further analysis of the research data.
The research was funded by goBalto, the industry leader in study startup.
Director of Sponsored Research Programs & Associate Professor
Tufts Center for the Study of Drug Development
"Why is Study Startup still so inefficient? This has always been a difficult area to understand, it's difficult to understand why there is so much variation and why there are so many inefficiencies and delays. That was the impetus behind this follow-up study."
Clinical Performance Partners
"The main reasons why some sites do not get activated relates to budgets and contract negotiation issues. We have heard that response in the past and it was further reinforced here. It almost seems like the industry has an acceptance of inefficiency. A lot of effort, resources, and time will go into identifying and activating sites. But for some reason, the industry seems willing to accept the fact that they will have to account for this level of waste in the system. That is a fairly high threshold for inefficiency."
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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