Great Expectations for the eTMF

 We all want more out of our electronic trial master files (eTMF). More functionality. More strategic capability. Better business process. That’s the word from Sharon Ames, Enterprise Program Director for NextDocs, a provider of eTMF and compliance solutions. Ames is referring to the fact that the eTMF industry is starting to mature, and has evolved beyond the early adoption phase from several years ago, when discussions focused mostly on the transition from the paper trial master file to an electronic version. 

 

According to Ames, “Making the move to electronic is a goal of many companies that are still using paper, but now, people expect more. The eTMF is not just an electronic document repository anymore.” 

 

Sharon Ames

Specifically, Ames says that stakeholders are now viewing the eTMF as a document management system that allows users to author documents at the beginning of the study and optimize business process for functional contributors along the way. Also, the mature eTMF customer expects to use the metadata associated with the documents to provide valuable business insights. “By looking at the metadata, companies can assess factors such as cycle times for document completion, and identify issues in document processing by person, study, country, or region,” Ames explains. 

 

From the sponsor’s perspective, the eTMF is seen as housing a wealth of data, and tapping into it is the next horizon. “This is exactly where the dialogue is,” says Ivan Walrath, Trial Master File Business Process Owner at Pfizer. “As we move past the eTMF as an electronic file cabinet, we are just starting to understand that we have a great opportunity to use all of the data in the eTMF, that it has incremental business value. We can do analyses on issues in clinical trial execution that we see are trending, such as, are there issues with the protocol? With CRO performance? With site performance? We’ve got all of this data to mine. How can we use it?” asks Walrath.

 

Walrath comments that Pfizer first implemented an eTMF in 2000, but updated to a more full-featured version built in 2011 by Wingspan, an eTMF provider. With its current eTMF, Pfizer is working to tap the extensive information it houses, which Walrath says offers two key benefits. “First is benefiting from the overall visibility, transparency of the completeness of the eTMF. Second is using the information and metadata to identify potential areas of concern that the company would want to investigate,” He explains further that anticipated improvements aren’t so much about cycle time issues, as they are about limiting or avoiding rework. For example, reducing the numbers of missing documents throughout the trial, and making sure all of the documents have the proper electronic signatures are hugely helpful instead of waiting until the study ends to discover these rework issues.

 

Walrath says the biggest challenge to implementation was not the technology, but changes to business process focused on continuous improvement. Given these changes, Pfizer has attempted to quantify improvements linked to the eTMF. Walrath says that in the 12 month period following implementation of the updated eTMF, the company saw a 50% improvement in eTMF quality, as measured by completeness and accuracy. He adds, “Definitely, going forward, Pfizer plans to keep more metrics.” 

 

The eTMF, the electronic version of the essential documents that enable the conduct of a clinical trial, mostly started as web-based and was maintained on in-house client servers. As technology has evolved, eTMF providers have cloud options, which offer increased visibility among stakeholders, an ability for documents to be always audit ready, and capability for functioning as a business planning tool, all without having to maintain the IT infrastructure in-house. Ames of NextDocs says, “Everybody wants to have the cloud conversation. People aren’t fearing the cloud the way they were a year or two ago.” 

 

Ivan Walrath

But there is a long way to go in eTMF acceptance. The 2013 NextDocs State of Trial Master File survey indicates that 28% of respondents are still using paper systems to handle clinical trial documents. Twenty-four percent report using a commercial eTMF; 22% use a shared file system; and 20% use a hybrid approach. But other data indicate that the eTMF is gaining traction. Results from the 2013 survey from the Drug Information Association (DIA) TMF Reference Model group show that 13% of respondents use a fully electronic system, as compared to 7% in 2010. The hybrid paper/electronic approach is proving popular, with 42% of respondents reported using it, versus 27% in 2010. 

 

Walrath observes, “We have seen a dramatic shift in the past four years. When we go to TMF summits, the dialogue four years ago was that everybody was using paper or people were scanning in documents. Now, many are in the middle of the transition to eTMF, and we are starting to see the dialogue around the incremental business value that it offers.”