More than four years and hundreds of clinical trials later, Eli Lilly’s Nicole Sheetz is an even bigger believer than before in the power of electronic trial master files (eTMFs) to improve study transparency, oversight, and quality—but cautions others about the importance of addressing and changing any holdover “mindset” that fails to immediately recognize the tool’s value.
Circa 2014, trial master files “were not telling the story of our clinical trials they way we wanted them to,” Sheetz told attendees of the 2019 North American R&D Summit sponsored by Veeva Systems in Philadelphia yesterday (September 9). She’s an advisor for clinical systems and supply planning, among other functions, at Lilly. The big pharmaceutical company currently has some 531 studies in its eTMF, Sheetz said.
Leveraged to its full potential, an eTMF system should be “an integral” part of clinical trial operations and not treated as an afterthought or “burden,” Sheetz said. Too often, and at Lilly in days gone by, users tended only to use the system when they were in a now-and-then annual clean-up mode, she noted. Changing that “mindset was our biggest challenge in 2016” when we decided to “reset” how we approached the system, she said.
However, Lilly’s root cause analysis revealed other eTMF implementation issues to address, Sheetz said, including:
- “We had unclear accountability for all records,” she said. It’s incredibly important to secure a “single point of accountability for each document” if possible, she added.
- Change management. The index change management process at Lilly circa 2014 was not well defined.
- Lack of training. Lilly “underinvested” in training and performance support, Sheetz said.
It’s also vital to instill a meaningful accountability structure into any eTMF buildout. Lilly implemented a cross-functional accountability model that manages process, training, indexing, system functionality and configuration, and overall communication, Sheetz said.
Today, Lilly is ahead of where it projected itself to be about five years into the project, Sheetz added. In fact, 2019 is going to be the year of “optimization” and building on successes, she said. While the years of 2016 and 2017 were a bit “shaky,” she said she’s pleasantly surprised by the speed and power of the rejuvenated eTMF program. “I didn’t expect us to be in the optimization [mode] already in 2019,” she explained.
At Lilly in 2019, the eTMF “is an integral part of clinical trial execution that facilitates the way we work and provides evidence of what we do throughout the life of the trial,” Sheetz added.
Author: Michael Causey