Clinical trial practitioners and new technologies continue their tentative dance toward mutual acceptance, as a new survey shows usage on the rise but at a sometimes-disappointing pace.
“We’re seeing that the industry is making progress in adopting more purpose-filled clinical applications, but there’s still a heavy reliance on manual processes and legacy systems,” says Jim Reilly, vice president for clinical strategy at Veeva.
Veeva’s 2019 Unified Clinical Operations Survey Report culled from the experiences and opinions of 461 clinical operations professionals from around the globe. Findings show the industry is making progress in unifying clinical systems, streamlining end-to-end processes, and aligning stakeholders to improve trial performance.
Standalone eClinical applications, including for electronic data capture (EDC) (88%), electronic trial master files (eTMF) (69%), and clinical trial management systems (CTMS) (61%) are now utilized by the majority of sponsors and contract research organizations (CROs) as they steadily adopt function-specific technologies to support clinical trials.
Nearly all (99%) respondents report the need to unify clinical applications to achieve better visibility and oversight (70%), faster trials (63%), and easier stakeholder collaboration (61%).
Consistent with the aim to improve collaboration, all respondents say they want to improve methods of information exchange between sponsors, CROs, and sites. Primary reasons include reduced manual processes (71%), improved collaboration (66%), and better visibility and oversight (64%).
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All respondents report significant challenges with study start-up, likely due to the heavy reliance on manual processes since most (81%) use spreadsheets to manage start-up tasks.
Sponsors and CROs report having made progress modernizing major clinical areas such as eTMF to ensure a constant state of inspection readiness (60%) and increase visibility into TMF status (58%).
Most respondents (95%) cite the need to improve the use of CTMS in clinical operations. Top drivers are improved reporting (68%), increased visibility (60%), and more proactive risk mitigation (58%).
The life sciences industry is experiencing rapid innovation and bringing novel drugs to market at an accelerated pace, according to the survey. In 2018, the industry achieved a record-setting number of 59 drug approvals, compared to 46 approvals in 2017 and 22 in 2016. As the impetus for speeding breakthrough drugs and treatments to market faster continues to intensify, organizations will have a greater need for improved trial efficiency and visibility.
Over the past several years, sponsors and CROs have steadily adopted function-specific technologies to improve study execution. The most popular is EDC, used by 88% of the CROs and sponsors surveyed. More than two-thirds (69%) have eTMF applications, up from 57% in 2017. Randomization and trial supply management applications (63%) increased 21 percentage points, likely due to rising protocol design complexity.
Majorities of the respondents also use CTMS (61%) and safety applications (53%). Nearly one-quarter (23%) have now adopted newer, purpose-built study start-up applications.
“I would have expected there to be more improvement in the collaboration and information exchange area,” Reilly says. When CROs, sponsors, and sites work together today, there’s still lots of “e-mails and portals and even still faxes of paper documentation,” he says. “If you’d asked me five years ago, I would have thought we’d be [further along in technology adoption for this], but there hasn’t been that degree of innovation yet in terms of improving information exchange.”
Author: Michael Causey