Seth Goldenberg, Phd, vice president of Vault Medical Device & Diagnostics at Veeva SystemsVeeva Systems
Fragmentated processes and system silos are slowing down clinical trials in the medical device industry, according to a survey from Veeva Systems.
The Veeva 2019 Unified Clinical Operations Survey looked at 461 clinical operations professionals from around the world. Veeva said its annual research “details the drivers, barriers, and benefits of a unified clinical operating model and tracks the industry’s progress in its move to bring together clinical systems and processes and align stakeholders throughout study execution.”
One of the most glaring findings from Veeva Systems report was the need for better communication between clinical trial stakeholders.
“Information sharing across sponsors, contract research organizations [CRO], and sites is something that people really want and need to be successful in running these studies,” Seth Goldenberg, PhD, vice president of Vault Medical Device & Diagnostics at Veeva Systems, told MD+DI. “100% of respondents said they need improve information exchange among study partners.”
He added, “I think a lot of it is that so much of it is manual process. When you look at what we’re trying to do, especially in the medical device industry … each of these stakeholders has a different view. If you’re a site – unless you’re Human Factors or Phase 1 site – your main goal is to treat patients. It’s not that people don’t want to share information, but it’s that their first jobs are; treating patients; collecting the data in the right way; and being compliant. Everyone wants to do that, so they’re not always so great at sharing information.”
Veeva said the survey revealed that on average, respondents utilized at least three methods to share trial data and documents among sponsors, CROs, and sites, with email as the primary tool. Majorities say the move to streamline information exchange is driven by the need to reduce manual processes (71%), improve collaboration (66%), and increase visibility and oversight (64%) during trials.
Nearly 99% of sponsors and CROs say they also need to unify clinical applications for greater visibility and easier collaboration. Many of the challenges in managing trials stem from siloed processes and systems that prevent a complete view of study progress and slow trial execution. Integration (68%) and reporting (57%) are the top two issues cited – both are the direct result of clinical system silos.
Study start-up is one of the clinical areas with the most potential to improve trial efficiency and speed. All respondents report significant challenges with study start-up, likely due to the heavy reliance on manual processes since about 81% use spreadsheets to manage this area.
Sponsors and CROs are increasingly adopting purpose-built study start-up applications to speed cycle times. Nearly 23% of respondents are now using newer, purpose-built study start-up applications.
Findings show that the majority cite faster study start-up times (71%) as the primary driver to improve study start-up processes. Half of respondents (50%) say easier collaboration during study start-up is also an area of improvement, highlighting the importance of collaboration in driving clinical trial efficiency and speed. About 50% of respondents said easier collaboration during study start-up is also an area of improvement, highlighting the importance of collaboration in driving clinical trial efficiency and speed.
Veeva said the startup of a clinical trial was so important and noted inefficiencies in this space could cost trial sponsors up to $2 million per month.
“This is why we’re seeing in the data such a push to modernize systems and processes,” Goldenberg said. “We absolutely as an industry have to encourage disruptive technologies that enable data-sharing and collaboration. That is the only way the industry will be able to bring new and novel breakthroughs … to market.”