When you think of the pharmaceutical industry, you probably do not picture firms that are anxious to jump on new technologies, or willing to adopt new tools that have not been proven successful. New technologies are now available to facilitate the collection of data in clinical trials, yet Big Pharma and CROs are not climbing over one another to be the early adopters. So is it really surprising that with electronic trial master files (eTMF) now available to clinics, and bearing the blessing of the FDA, that many sites continue to amass large volumes of paper?
To better understand the issues presented by lagging technology adoption, Veeva Systems undertook the largest-ever survey of trial master file users. The effort, titled Veeva 2014 Paperless TMF Survey: An Industry Benchmark, examined 252 TMF owners and found a majority of them still using paper or electronic file systems to manage their TMF. The survey also found that companies using advanced eTMF technologies, including content management systems and purpose-built eTMF applications, experienced greater inspection readiness, visibility, SOP compliance, and cost savings than those using local or cloud file systems.
The savings incurred by companies using the more advanced technologies were not minor. The survey found only 29% of firms using a local file system experienced cost savings. In comparison, 47% of those with an eTMF application, like Veeva Vault eTMF or Wingspan eTMF, experienced cost savings. Nowadays quality is a goal that seems to be a top priority for every company. eTMF can help in this regard as well. The survey found 81% of companies with an eTMF application noted good or major improvement in the incidence of misfiled documents. Only 62% of users with their eTMF on a local file system reported similar results.
With these cost and quality metrics, you would expect to see adoption of eTMF soaring. Unfortunately, only 13% of the sponsor-companies responding reported using an eTMF application.
Why the continued reliance on manual practices? It seems some companies remain reluctant to sharing trial documents by means other than paper and email. The survey found the predominant means of exchanging trial documents with sponsors and CROs was email (69%) and paper (57%).
Visibility Is A Primary Concern
At a recent conference I attended, a Big Pharma executive was lamenting a warning letter the firm received years prior, and how that was a wakeup call to needing more visibility into its outsourced trials. While that visibility can be difficult to achieve with paper and electronic file systems, the Veeva survey found advanced systems fit the bill. Nearly half of the firms with an eTMF application reported greater visibility into trial performance metrics, versus only 25% of cloud file system users. Those firms extensively using metrics to improve their trials were also more than twice as likely than those not using metrics to report improvement from their eTMF in the areas of TMF document quality, audit readiness, and SOP compliance.
Jennifer Goldsmith, VP of Veeva Vault, notes historically the industry has tended to focus on the rate of eTMF adoption in broad, general terms. However, with the in-depth data provided by this survey, the company was able to gain an understanding of which eTMF technologies, processes, and metrics are driving improvements. “Technology is a key aspect, but we now know the use of metrics to optimize trial operations is also having an impact,” says Goldsmith.
Put The Blame (And Benefit) On Cost
Although the FDA created regulation CFR 21 Part 11 to support the use of electronic records and digital media/signatures in clinical trials, 28% of respondents still cite regulatory requirements as a major or insurmountable barrier to going paperless. That barrier came in third, behind technology cost (38%) and implementation costs (33%). Ironically, 38% of respondents cited cost savings as a result of adopting an eTMF solution.
The results make it clear that while many companies fear the cost of implementing an eTMF platform, the cost savings realized from such a move can easily erase those costs in a short amount of time.
In order to make the move to a paperless system, the top requirements cited by those taking the survey were digital/e-signatures (66%), electronic forms (65%), and secure access for external parties (62%).
Additional highlights from the survey include:
Types of eTMFs in Sponsor Organizations
Benefits Attributed to eTMF Solution
Use of Metrics