Up until recently, the increasing complications and timelines involved in clinical study start-up have not seen any true benefits from technologies that have helped in other areas of trial management, says Ashley Davidson, director of Vault Study Startup for Veeva Systems. In fact, she notes, inappropriate use of technology has possibly contributed to the problem.
“It’s still baffling to me today to see companies still lumbering along using so many spreadsheets” to handle study start-up tasks, Davidson offers as one example of antiquated practices. In her ACRP 2019 presentation on “GPS for Study Start-Up: The Importance of the Critical Path” in Nashville on Monday (April 15), she also pointed out the disconnect between data and processes that arises from using homegrown or retrofitted systems for start-up tasks that were never intended for such activities, or relying on poorly integrated point solutions or platforms.
However, technology is getting the clinical research enterprise to the point of being able to intelligently guide researchers through the “Critical Path,” or the longest path of planned activities and milestones required to be completed in order to ensure on-time site activation and study start-up. This is welcome, Davidson says, because “study start-up is all about speed, so if we’ve accounted for any of these [Critical Path tasks] incorrectly…it’s very costly to get your planning wrong up front.”
According to the 2018 Veeva Unified Clinical Survey, 83% of respondents say their companies are taking action to streamline study start-up, Davidson notes, but she adds that the solutions can’t all be about the technology being used. In part, this is because study start-up “doesn’t happen in a bubble,” she explains—it touches on many parts of the ongoing study, as well.
“I actually don’t think technology is what’s going to solve” the study-start up dilemma, Davidson says. She believes technology needs to come together with people and processes in a risk-based approach that increases transparency and collaboration across the study team, takes a holistic view of study start-up as an end-to-end process, and allows researchers to measure and optimize start-up processes.
Author: Gary Cramer