The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.DeviceTalks
Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future?
Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research (now Avania); Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulatory affairs at Hologic.
Four takeaways from the pivot to remote monitoring of trials are:
1. Virtual monitoring has not hurt quality or safety
The issue with trials during the pandemic, Kolodziej said, was getting trial data because enrollment was down. But the panelists and most audience members participating in real-time polls agreed that remote trial oversight did not decrease the quality of clinical trials and was safe for study subjects.
Medtronic’s Lefebvre said that in shifting to virtual monitoring, Medtronic carefully assessed the outcome of visits. “We have seen no difference in terms of the overall quality or the overall outcome of the visit with respect to the data quality,” Lefebvre said. Chittester from Avania and Baird from Remington-Davis agreed, seeing no negative impact and perhaps an increase in the quality of clinical trials because of the ability to monitor the trial in real-time.
2. Remote trial monitoring has decreased trial costs
Among DeviceTalks Tuesdays participants, 59% believe remote trial oversight has decreased the costs of clinical trials and 22% say remote trials have not impacted costs; only 19% believe costs have increased.
Preparation for a remote visit takes 1.5 to 2 times longer, Baird and Lefebvre said. But, according to Lefebvre, “The actual visit is shorter, more efficient, more effective. So, the additional prep time is offset by the time now gained during the monitoring visit. And, the follow-up is also a little faster.” The other significant benefit is the elimination of travel time and expense.
IMARC’s experience has been similar. “It seems an overall cost savings,” Chittester said. Spending extra time on visit prep and even paying sites a bit more for prep is more than offset by the reduction in travel time and expenses.
3. The adoption of various technologies has increased
“Technology is being embraced,” Chittester said. “We can have access to medical records on a different pace or schedule than before.” The specific types of technologies embraced vary for every organization but include technologies to provide access to EMRs and to enable secure data sharing.
“We’ve invested in technologies to help facilitate remote monitoring visits,” Kolodziej said. His organization implemented eSOURCE, a commercially available electronic source documents system. Sponsors want to know what technologies are in use and that these technologies are compliant with all applicable regulations.
4. Remote monitoring and hybrid trials are here to stay
The panel believes that a sea change has occurred for all players in the clinical trials ecosystem. “I look at COVID as having enabled us to really have a tremendous transformation in clinical trial execution,” asserted Lefebvre, speaking from the perspective of a trial sponsor.
“Remote monitoring is here to stay,” Kolodziej said. “If we want to play ball, then we’d better get in the game and make sure that we figure things out and make sure it’s efficient and works for everyone.”
The presence of remote monitoring creates more options for the future, including hybrid approaches that involve both on-site and remote oversight. “When we think of hybrid, it’s the mix of on-site and remote,” Chittester said. “There are so many places we can go . . . definitely a lot of options for how we can run trials in the future using this combination of on-site and remote.”
For Kolodziej, the concept of hybrid is not just for monitoring but also involves “data hybrids” where data comes from multiple sources, such as both prospective trials and real-world evidence. He believes data hybrids can help expedite regulatory approval.
“I don’t think we’re going back to where we were,” Lefebvre said. “At the same time, I don’t think we’re going to stay at the level we’re at today in the U.S., where 95% of monitoring visits are done remotely.” For Medtronic, he predicted that over time, around 50% of visits in Europe will be remote and perhaps around 60% to 70% in the United States.
Provided to Medical Design & Outsourcing by BullsEye Resources.