While the benefits of using mobile technologies in clinical trials are self-evident to many in the industry, patients may still need some encouragement, says Virginia Nido, Global Head, Product Development Industry Collaborations, with Genentech, a member of the Roche Group.
For example, some patients may balk at learning they won’t be making as many physician visits. Clinical trial practitioners might talk up the convenience factor, yet patients might see using a device to participate in a trial as a net negative in the treatment regimen if they lose face time with a doctor.
Other groups might be wary of using yet another device in their treatment. For example, the rheumatoid arthritis (RA) patient population already uses several devices in their day-to-day care in assisted living facilities and elsewhere. “Will they want to use another?” Nido asks. “Will RA caregivers?”
Addressing any human factor-related challenge is difficult without meaningful data. That’s why the Clinical Trials Transformation Initiative (CTTI), a public-private partnership founded by Duke University and the U.S. Food and Drug Administration, is working on extensive patient surveys it hopes to unveil in early 2018.
CTTI fostered the Mobile Clinical Trials (MCT) Program to facilitate transformation of the clinical trials enterprise through appropriate use of mobile technology. It’s looking at regulatory issues, use of mobile devices, novel endpoints, and patient and community provider views of mobile technology.
For now, CTTI is looking for input on methodology, Nido said. She’ll moderate a panel at the upcoming ACRP 2017 Meeting & Expo in Seattle designed to give industry a status report on CTTI’s activity to date. She’ll be joined by Linda Coleman, director of the Human Research Protection Program at Yale University; Phil Coran, senior director for quality and regulatory affairs at Medidata Solutions; and Matt Kirchoff, clinical research operations manager for international research pharmacy operations with National Institutes of Health/National Institute of Allergy and Infectious Diseases.
“This type of technology can’t wait,” Nido says, calling it “critical” to the advancement of clinical trials. It offers the chance to generate more accurate and flexible data in real-time settings. However, adoption will be an uphill climb unless patients share that enthusiasm, Nido notes.
Author: Michael Causey