According to Veeva’s 2019 Unified Clinical Operations Survey, all respondents agreed there is a need to improve information exchange among sponsors and contract research organizations (CROs), and sites – which use, on average, three methods to share clinical trial data, primarily, email.
Compared to last year’s survey, Jim Reilly, vice president Vault Clinical at Veeva Systems, said there was a significant focus on collaboration and improving information exchange during trials. “It’s a top priority this year,” he told us, “with 100% of respondents saying information exchange is an area of improvement.”
Reducing manual processes (71%), improving collaboration (66%), and increasing visibility (64%) during trials, are driving the need to ease information exchange, per the report.
“Over the past several years, sponsors, and CROs have steadily adopted function-specific technologies to improve clinical trial execution,” said Reilly.
An example of this, the adoption of electronic trial master files (eTMF) has tripled since 2014, he explained, though historically siloed systems and manual processes still impede efficient trial conduct.
The top two issues cited by survey respondents were integration (68%) and reporting (57%).
“So, there is industrywide urgency to streamline how trials are run. And sponsors and CROs are accelerating their move to modern systems,” added Reilly. “Two areas ripe for change are improving information exchange among study partners and accelerating study start-up – both are key to driving greater efficiency and speeding trials.”
Reducing study start-up time was cited by (71%) as the primary driver to improve the process, per the report, with all respondents reporting “significant challenges” during start-up, in part due to a reliance on manual processes – as 81% said they use spreadsheets to manage this aspect of the trial.
As Reilly explained, “while the industry is making progress adopting advanced clinical applications, there is still a heavy reliance on manual processes and legacy systems in certain clinical areas,” he said.
Consistent with last year, respondents also reported widespread challenges with clinical trial management systems (CTMS). Reilly said, nearly all sponsors and CROs (95%) are reporting major issues. “It’s an area where legacy systems are still very prevalent,” he added.
The industry also is seeing “transformational change in study quality and compliance with the use of purpose-built eTMF solutions,” said Reilly. Since Veeva ran its first survey in 2014, eTMF has “really matured,” he added. Among those using purpose-built eTMFs, 60% reported a positive effect on inspection readiness and a similar percent cited improved visibility into TMF status.
“Last year we saw a record number of drug approvals. But the time it takes to run a trial is no faster, and the cost of developing drugs is rising. Not to mention there are increasingly more stakeholders involved,” Reilly added.
“It’s why there is an industrywide need to unify clinical systems and processes,” he said. “For more than half of sponsors and CROs, better visibility, faster trials, and easier collaboration are main drivers to unify their clinical environments.”
