From The Editor | June 16, 2014

eTMF Survey: Lagging Technology Adoption Will Impact Clinical Trials

Source: Veeva Systems

By Ed Miseta, Chief Editor, Clinical Leader
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Ed Miseta

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

  • The most common eTMF is a file share, with 26% of respondents report using a local file system and 18% a cloud share.
  • Content management systems accounted for 30% of eTMFs in use.
  • Advanced eTMF applications were used by 13% of respondents.
  • 13% of respondents had not used an electronic TMF.

Benefits Attributed to eTMF Solution

  • Those using an eTMF application or a content management system achieved greater benefits than those using a local or cloud file system, including:
  • Real-time tracking and viewing of documents (65% vs. 71%)
  • Easier to search and find documents (69% vs. 61%)
  • Improved audit and inspection readiness (51% vs. 28%)
  • Cost savings (45% vs. 31%)
  • Better visibility into key trial performance metrics (44% vs. 28%)

Use of Metrics

  • Organizations that report extensive use of metrics to improve trial execution and design realized a greater number of eTMF benefits than those that do not collect data or utilize metrics.
  • Improved document quality/reduced QC findings (63% versus 29%)
  • Improved audit and inspection readiness (56% versus 25%)
  • Easier collaboration with sites (54% versus 32%)
  • Increased TMF SOP Compliance (49% versus 16%)
  • Twice the proportion of TMF owners report that their organization is not using metrics to improve trial processes (39%) compared to those organizations extensively leveraging metrics to improve execution and/or design of trial processes (20%).