Clinical trial professionals who’ve got ideas about how to better conduct medical device trials will have their opportunity to make a difference at the ACRP 2019 meeting in April in Nashville, Tenn., says Stephanie Christopher, MA, CCRC, FACRP, program director at the Medical Device Innovation Consortium (MDIC), a public-private partnership that focuses on regulatory science issues. MDIC has also worked with the U.S. Food and Drug Administration and industry partners to engage patients and the broader public on such issues as fostering better patient engagement in device trials.
“I’ve long contended that it’s important to bring [into the conversation] the research professionals who are actually doing the studies,” Christopher says. “It’s one thing to talk to folks who are designing the studies—and they of course play a valuable role—but it’s another conversation to talk to people who are actually the ones consenting patients and enrolling them into clinical trials.” ACRP 2019 attendees will “bring a valuable perspective that I hope we can learn from,” she adds.
There are number of differences between types of trials for medical devices versus trials for drugs, notes Matthew McCarty, senior director and global head of patient engagement for ICON, plc. and member of MDIC. For example, with a trial of a surgical implantable device, deciding to participate or not is a very different type of process for a patient. They’ve got to factor in the surgeon and the risks of the procedure versus a daily or weekly drug dosing schedule, McCarty says.
Tools for Advancing Patient-Centered Medical Device Trials
Join Stephanie Christopher at ACRP 2019 this April to learn about a new suite of tools developed by MDIC to help medical device companies solicit input from patients and patient groups on clinical trial design elements that are aligned with patients’ real-world priorities. Learn about the development of these tools and how you can implement them to develop clinical trials that measure what matters to patients and that patients can complete.
Further, if a study involves an in vitro diagnostic device, “you’re essentially recruiting healthy volunteers versus a particular patient population,” McCarty says. One of the things the MDIC is focused on, he says, is “what’s already been done that’s usable in the drug space…[and] how do we help [the device and diagnostic side] get this right given the differences” in the overall drug and device development industry?
“We need to know what the barriers are and what ways we can motivate patients to participate in device trials more,” adds MDIC member Michael Otlewski, MS, a clinical program specialist with MED Institute, Inc.
MDIC is developing several reports scheduled for release later this year, and a framework report for release in 2020.
Author: Michael Causey