TMF Survey: Major Changes To Clinical Operations

By Ed Miseta, Chief Editor, Clinical Leader

Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.

This year’s results, presented in a session at the Drug Industry Association’s Annual Meeting in Philadelphia, represents the opinions and experiences of 217 TMF owners from around the globe. The overall goal of the survey is to understand the impact of eTMF adoption on clinical processes, as well as the drivers, benefits, and expectations of eTMF solutions.

One of the items tracked in the survey is the type of eTMF solution in use, which can vary widely in both capabilities and fit for managing a TMF. The survey finds there has been a significant shift from passive systems, such as local file systems, cloud file shares, and static repositories, to active systems, designed specifically to manage TMF documents and end-to-end processes. This shift has been underway since 2014, and during that time sponsors’ use of advanced eTMF applications has increased nearly twofold to 24 percent. During that same period the use of local file systems as an eTMF has fallen from 26 percent to just 8 percent. The use of cloud file shares, content management systems, and paper-based TMFs remained flat.

Digital Enables Better Partnerships

The most common processes sponsors conduct electronically are the archival of documents, creation of source documents, and collaboration with external partners (all between 44 percent and 56 percent). Not surprisingly, with the move to electronic systems, there has been a marked increase in the use of electronic means to manage the TMF and work with trial partners. There has been a 14 percent increase since last year in sponsors collaborating with partners electronically. Perhaps even more surprising is the fact that only 22 percent of sponsors use electronic signatures (eSignatures) for documents, despite its broad acceptance on almost all TMF documents by regulatory agencies worldwide.

There is good news. The survey found sponsors are increasingly exchanging TMF documents with external parties in a single system accessed by all study partners. Almost a quarter of sponsors reported using an eTMF application to exchange documents with CROs. In 2014, only 14 percent were doing so. Sixteen percent are using an eTMF to exchange documents with sites, up from 11 percent in 2014. Approximately 70 percent use email for the exchange of documents with both CROs and sites.

eTMF is also used when working with auditors and inspectors. The survey found 80 percent of respondents using an eTMF to provide remote access to auditors and inspectors, or planning to do so within the next year. This was a 13 percent increase over 2015.

Barriers To Going Paperless Remain    

Several factors continue to drive the implementation of eTMF systems. The business benefits most cited by respondents include improving inspection readiness (67 percent), speeding study start-up (53 percent), and providing remote oversight of the TMF (48 percent). Improved inspection readiness was up 16 percent from 2014, likely motivated, at least in part, by the MHRA’s (U.K. Medicines and Healthcare products Regulatory Agency) 2014 mandate. The mandate notes incomplete or inaccessible TMFs could be a critical good clinical practice (GCP) finding.

Study startup continues to be an area of interest for life science companies, and was also noted as a top driver for eTMF adoption. However, the percentage of sponsors citing that as a consideration only changed by three percent between 2014 and 2016. Better visibility into performance metrics (40 percent), cost savings (35 percent), and easier collaboration (29 percent) were additional business drivers cited by survey respondents.

Despite those drivers, barriers still remain and are keeping companies from going to a fully paperless TMF. The survey asked sponsors which capabilities their organizations still require to move to a fully paperless TMF. Sixty-one percent of sponsors with an eTMF application reported digital/eSignatures, a number consistent with the low number (22 percent) of sponsors who reported they are currently using eSignatures for TMF documents. The second barrier, cited by almost half of sponsors, is the need to integrate their eTMF application and clinical trial management system (CTMS). Half reported secure access was a required capability while 46 percent reported needing TMF tracking and reporting. The report notes these findings confirm the trend to unify clinical operations systems, processes, and stakeholders for increased visibility, improved inspection readiness, and shorter clinical trials.

Do Benefits Outweigh Costs?

Finally, the benefits achieved from an eTMF application were noted by those that have implemented the systems. Sixty-one percent of users with a purpose-built eTMF application cite improved audit and inspection readiness, which is up 14 percent from 2014. Users with other types of eTMFs were less likely to cite audit and inspection readiness as a benefit.

The survey then attempted to drill deeper into those findings. Nearly all respondents with an eTMF application reported significant improvements in at least one category, and half reported significant improvements in all categories noted in the survey. The issues most cited as improving inspection readiness related to duplicate documents, missing documents, and documents that are incomplete or missing a required signature.

By almost a two-to-one margin, those using an active eTMF application were more likely to see improvements in central and remote monitoring as compared to users of passive eTMFs. The benefit was reported by 59 percent of eTMF application users, compared to just 37 percent of those using a local file system, 36 percent using a content management system, and 31 percent using file share. Almost half of respondents also cited central/remote oversight as a top driver of eTMF adoption, likely due to its ability to significantly reduce the number of onsite visits required by a monitor, allowing sites to focus on research and reducing study costs.

The survey consisted of 13 questions, many of which included sub-questions. Survey completion was, of course, voluntary and a donation was made to Doctors Without Borders for each valid completion. Of the 217 qualified responses received, 64 percent were from sponsor companies. The remainder were from consultants and CROs. Seventy-seven percent of respondents were located in the U.S.

For more information contact etmfsurvey@veeva.com or click here to receive a copy of the survey.