Over the past decade study startup, encompassing the activities associated with site identification, feasibility assessment, selection and activation, has become a priority improvement area in the conduct of clinical trials.
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.
Numerous factors can adversely impact study startup and its efficiency, in an industry plagued by rising development costs and increasing complexities. It's difficult to understand why there is so much variation and why there are so many inefficiencies and delays in study startup, this was the impetus behind this research. In a recently completed comprehensive study, The Start-up Time and Readiness Tracking (START) II, 2017 conducted by Tufts Center for the Study of Drug Development (CSDD) a significant difference in cycle times between new vs repeat sites and organizations (sponsors vs. contract research organizations (CRO)) was observed, however the percentage of sites never activated remained at 11%, a figure which has not changed substantially in over a decade. The primary reason cited was budgeting and contracting problems, which has been a challenge identified in much published work. Given the new technology solutions and practices, as well as, the increasing number of dedicated personnel managing site relationships it's surprising and disappointing that the industry has not been about to make any headway in reducing the number of non-active, non-enrolling (NANE) sites.
Given the plethora of new approaches and solutions now being deployed to improve the study startup process the Tufts CSDD research provides a baseline upon which future studies can be conducted to gauge progress. The study was funded by an unrestricted grant from goBalto, a technology solutions provider.
The START II research 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.
The research was funded by goBalto, the industry leader in study startup.