Nevro medical device company, headquartered in Redwood City, California, focusses on developing new technologies and innovations designed to improve the quality of life for patients with chronic pain, they are the makers of the Senza spinal cord stimulation (SCS) system. Senza is an evidence-based, non-pharmacologic neuromodulation platform that utilizes Nevro’s proprietary 10 kHz Therapy to ease debilitating nerve pain.
Making the Jump into ePRO
Nevro’s current research focus is expanding clinical evidence for its Senza device. Having historically collected patient data using paper, the Nevro team wanted to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments (ePRO).
“When we were using paper questionnaires, there was a lot of transcription. Some of our questionnaires are nearly 50 questions long,” said Frances Rubenstein, PhD., Director of Database Management at Nevro. “The fact that the research coordinators (RCs) had to just sit there and transcribe it all took up a lot of time.”
For more on this transition, read about ePRO vs. paper strategies in clinical trials
The company chose to work with Medrio to help implement an ePRO solution that would be easy to adopt and intuitive enough to scale across their studies, which range from relatively straightforward to highly complex. They then sought to combine the new ePRO solution with Medrio’s similarly intuitive EDC platform to optimize efficiency.
Easy from Start to Finish
Medrio helped Nevro to take on the critical task of transitioning its existing library of paper patient assessments to ePROs. Medrio’s system allowed Nevro to quickly identify the content from the CRFs that would be most useful and relevant for the new ePRO system while trimming content that did not fit or add value. Medrio worked with Nevro to view how they build out ePRO questionnaires through the lens of both the patient experience and that of the RC collecting the ePRO data at the clinical trial site.
“There was a lot to consider in terms of how the user would interact with the ePRO. How would they hold the iPad, for instance,” Rubenstein said. “Medrio was able to help us optimize our questionnaires to make things as simple as possible for the person entering the data.”
Training also needed to be easy to minimize the burden for site-based study teams entering the data during patient interviews. Nevro created a video to help new users get acclimated to the Medrio ePRO solution, which they would interact with via an iPad.
“Users can see, very clearly, how simple the application is to use,” Rubenstein said. “The quick video tutorial has been very helpful for those study team members who were used to the paper processes and may have been a little resistant to change.”
Once ePRO data was successfully entered, it automatically populated within Medrio’s user-friendly EDC. For Nevro, the straightforward nature of the database buildout was a key point of differentiation from other EDC solution providers.
“I’ve spoken to other EDC companies that require their customers to have someone in-house that knows JavaScript or even deeper coding ability,” Rubenstein said. “With Medrio, all we need to know is how to write simple algorithms in Excel, which has saved a great deal of time and allowed us faster, easier access to our data.”
Sourcing a Better Way
Another advantage of ePRO is that data is collected directly from the source, either in-clinic by the RC, who is interacting directly with the patient, or remotely from the patients in studies that utilize decentralized approaches. In these cases where data is collected without transcription, source data verification is no longer needed. Eliminating even some need for verification can significantly reduce the time spent (and the cost of that time) performing this task.
“By transitioning to ePRO and using Medrio’s EDC, we have eliminated the amount of necessary source data verification by two-thirds,” Rubenstein said. “This has allowed clinical research associates (CRAs) to focus on other critical tasks, such as making sure adverse events and protocol deviations are handled correctly or ensuring that recruitment efforts are on track.”
Moving Forward in Partnership
The ease of use of Medrio’s EDC platform and its ePRO solution leaves the door open for Nevro to continue to innovate its studies. Nevro has conducted 25 clinical studies in collaboration with Medrio, with 10 currently active. Building on this positive momentum, they feel confident in the ability to involve new trial sites and, potentially, begin remote data collection directly from patients in their homes.
“We are thrilled with the impact Medrio is having on how we produce our clinical evidence,” said Rubenstein. “We have a strong relationship with Medrio, and their team has helped us build an effective process for collecting and accessing data that we can apply to all of our studies, today and in the future.”
