By Ann Neuer 

 

August 13, 2014 | Beyond the simple paper versus digital debate, there is growing interest in what the electronic trial master file (eTMF) offers in terms of tracking and measuring operational efficiencies of clinical trials. That’s what a new survey of 252 TMF owners hoped to explore. 

 

Veeva Systems’ 2014 Paperless TMF Survey: An Industry Benchmark, “focuses on the kinds of electronic solutions TMF owners are using, and not just on whether they are using electronic or paper,” explains Jennifer Goldsmith, Vice President of Veeva Vault at Veeva Systems. “When you advance beyond that discussion and start asking about the specifics of different electronic solutions, we see the benefits of each type varying dramatically, with most benefits aligning with an eTMF application.” 

 

To reach this conclusion, the Veeva survey gathered data on whether respondents were using a file share system, a cloud file share, a content management system, or a full eTMF application, which provides functionality specific to TMF documents and process-driven content management.  The company tallied the benefits of each as it relates to clinical trial operations. This level of detail was not captured in previous surveys, such as those conducted by the TMF Reference Model group within the Drug Information Association or by industry providers. Those surveys, along with Veeva’s, documented the continued reliance on paper, to the tune of approximately one-third of respondents, coupled with the ongoing uptake in electronic solutions. But Veeva’s findings were more extensive. For example, Veeva reported that use of paper differed substantially by department, with legal/contracts (53%), and clinical operations (43%) still heavily rooted in paper processes. By comparison, only 19% of biostatistics and 22% of data management reported managing most or all TMF documents on paper.  

 

 

 

Jennifer Goldsmith, Veeva Systems' VP for Veeva Vault 

 

In terms of eTMF uptake, the survey results showed that no single type of eTMF was predominant, but nearly half of sponsor-company respondents who use eTMFs reported working with a file share such as a local file system (26%), or a cloud file share such as an FTP site or dropbox.com (18%). Some 13% of respondents reported using an eTMF application, such as Veeva Vault eTMF or Wingspan eTMF, and 30% were using a content management system such as EMC Documentum or Microsoft SharePoint. 

 

Beyond these stats, however, Veeva took a careful look at how users are benefitting, based on the type of eTMF they are using. Specifically, Veeva sought insight into how different eTMFs rate in improving clinical trial operations, such as ease of collaboration with contract research organizations (CROs), audit and inspection readiness, and visibility into key performance metrics. In comparing the various types of eTMF, the survey revealed that those using an application dedicated to eTMF, rather than content management systems or file sharing systems, achieved the most benefit or the second most benefit in every category. Respondents reported the following results: 47% of those using an eTMF application cited better visibility into key trial performance metrics as a benefit of this solution. By comparison, 42%, 25%, and 31% of those using a content management system, cloud file share, or local file system respectively reported receiving better visibility. Similarly, in terms of cost savings, 47% of those using an eTMF application named this benefit, whereas 44% of those using a content management system, 33% of those using cloud file share, and 29% of those using a local file system did so. 

 

“These findings indicate that the eTMF application enables active management of the clinical trial, not just using it for archiving purposes,” Goldsmith comments. She is referring to the earliest versions of eTMF, which are frequently referred to “electronic file cabinets”, whereby paper documents were scanned and archived, and were not interactive or able to provide insight into the status of ongoing clinical trials.

 

Echoing the value of the eTMF application is Linda Sullivan, Chief Operating Officer of Metrics Champion Consortium, an industry association dedicated to the development of standardized performance metrics to improve clinical trials. She notes that companies are interested in an operational eTMF as part of a trend toward central data analytics programs, which provide decision makers with real-time access to data on how trials are proceeding. “Companies need data from multiple sources to be able to report on a site by site basis on what’s happening with the trial process. The newer generations of eTMF are dynamic in that they can report metrics that give users the transparency they need,” Sullivan says. 

 

 

 

She explains further that an eTMF system also supports efforts by sponsors and CROs to improve audit and inspection readiness by enabling processes that make sites ready on a continuing basis. That way, sites don’t have to focus on a lot of rework in a frantic rush to get ready for inspection. And ultimately, the data available in an eTMF application will allow companies to look across multiple studies to identify characteristics of study processes that are successful. 

 

“With this information, sponsors can begin to put procedures in place so those practices are adopted more broadly. This quality by design approach is where the market is headed,” Sullivan observes.