Veeva Systems, a California-based cloud computing company, recently released the 2017 Unified Clinical Operations Survey, their annual survey with clinical operation professionals. The results of the survey reveal a desire to unify applications across clinical operations.
According to the survey results, 99% of respondents cite the need to unify applications, including clinical trial management systems (CTMS), electronic data capture (EDC), and electronic trial master files (eTMF), across clinical operations. Veeva wrote in their publication of the survey results that faster study execution (65%) and improved study quality (63%) are the top drivers for a unified clinical model, according to the respondents, which is characterized by end-to-end processes and systems, seamless collaboration among stakeholders, and greater insights across the clinical lifecycle to improve study performance.
300,000 surveys were initially sent out to individuals who marked themselves as clinical operation professionals, and 1,000 of those were completed. From there, Veeva checked the qualifications of the respondents, making sure the respondents did hold clinical operations and if they were involved with a sponsor or a CRO. Of 1,000 completed surveys, 300 were certified.
Veeva has been conducting this survey since 2014, though the focus of the survey has changed over the years. Initially the survey was focused in on the challenges and opportunities surrounding moving the eTMF from primarily a paper set of processes and artifacts to an electronic set of processes and artifacts, Jennifer Goldsmith, senior vice president of Veeva Vault at Veeva Systems, told Clinical Informatics News.
“Part of the reason for that was that around that timeframe we started to see the global health authorities taking a much greater interest in how TMF information was being managed and stored. So in section readiness as well as quality timeliness metrics became very important for those organizations. Those first couple of surveys really focused in on that movement,” she said. “This last survey we shifted [the focus]. We started looking not just at the one component, which is the [eTMF], but really at the broader clinical ecosystem to understand from a clinical trial perspective what are some of the challenges and the opportunities facing clinical operations professionals today.”
The “challenges and opportunities” that clinical operations professionals face stem from the complexity of today’s clinical trial space. Goldsmith says there was a push several years ago towards outsourcing, with several products in the space today being codeveloped and comarketed. According to the results of Veeva’s survey, easier collaboration is a must-have among 52% of the global stakeholders surveyed in order to unify clinical operations.
A tangible result from this need can be found in the use of eTMF as opposed to paper TMFs. In the 2014 survey, only 13% of trial sponsors reported using an eTMF application. According to the 2017 survey, that number has increased to 31%. Also, only 16% of sponsors say their clinical operations departments use paper for most or all of their TMF documents. This is a notable change compared to the 2014 survey where 41% of sponsors were using paper.
“It doesn’t surprise me,” Goldsmith said when reflecting on this shift from paper to electronic trial master files. “What we’ve seen in the last two years is a massive shift for pharma, which, as you know, typically moves very slowly… Which I think has been driven [without any direct correlation] by a couple of key factors. One is the need to execute more quickly on all processes, the pressure to get things to market faster with less cost, as well as the need to increase quality overall.”
Veeva’s official release of the 2017 survey comments that “Modern cloud-based eTMF applications have a direct impact on improving collaboration. When asked what benefits were achieved after implementing an eTMF application, almost half (45%) of sponsors report easier collaboration with partners.” Goldsmith spoke about this statistic and its standing with the 16% of sponsors who still use paper TMFs. Geography plays a big factor in the continual use of paper, she said. “I would speculate that if you’re in an area of the world where you may not have access to the types of information systems you would have in the US or in Europe, that would prevent you from [using eTMFs].”
Overall Goldsmith is optimistic about where the clinical application space is going, and sees areas where both the space and the survey itself can improve.
“We need to dig a little bit more deeply into the why of why people find it important to have a unified environment,” Goldsmith said. “One of the interesting things to me were the challenges that bore out [the 99% agree on collaboration]. None of the systems today are highly unified or highly integrated… What I hope to see over the course of the next few years is that these challenges overall become less prevalent.”