The coronavirus pandemic's disruptions to clinical trials ought to spur permanent change to research infrastructure, physicians and regulators discussed during the Transcatheter Cardiovascular Therapeutics virtual event this past week.
Dexcom, Medtronic and Edwards Lifesciences are just some of the medtechs that have reported delays to clinical studies. In certain cases, delayed trials push back product approvals and launches.
Yale Medicine's Harlan Krumholz said experiences in 2020 have exposed the "frailties" and "deficiencies" in research infrastructure, in a keynote during a session on COVID-19's impact to the clinical trial ecosystem and regulatory approval studies.
"We talk a lot about innovation but we're not innovating within the research enterprise," Krumholz said in remarks.
Like many medtechs, Krumholz heralded the potential of real-world data, and usefulness of digital platforms, mobile technologies and wearables in opening new avenues for data collection. Yet those resources are "largely still sitting on the sidelines."
Also in support of remote data collection, Harvard Medicine's C. Michael Gibson predicted trends here to stay include phone-based communication and use of claims databases. Speaking also about pharma trials, Gibson noted that "this virtual approach has a lot of what we’re looking for," given that significantly less expensive trials means "more shots on goal."
Panelist Manuela Negoita, Medtronic's VP of global clinical affairs, said that in her company's experience, setting up technology to gain remote access to patients and sites was "an easy path." More complex was finding the right technologies and setting up the infrastructure to seamlessly remotely proctor cases. Negoita said as a result of disruptions to trials, Medtronic faced "very significant delays" to product approvals and has "had to find way to adapt the statistical methodology."
“It’s not easy to change the design of a trial in the middle of it,” Negoita said, and the company is still continuing to work on reducing the time to filing and approval.
Most ongoing trials were paused at least once as the public health emergency unfolded, said FDA's Bram Zuckerman, head of the division of cardiovascular devices. At the beginning of the public health emergency, FDA issued guidance on conducting clinical trials during COVID-19, which it's updated over recent months.
“The bottom line is that FDA strongly encourages modernization and optimization of the clinical trials ecosystem during this emergency and beyond,” Zuckerman said, naming integration of telehealth as one effort FDA supports. Zuckerman acknowledged that such change is easier said than done but also emphasized there are "no fundamental FDA constraints" on such an effort.
Trials are also taking a lot longer to finish during the pandemic, according to Tamara Syrek Jensen, who heads the Coverage and Analysis Group in the Centers for Clinical Standards and Quality at CMS.
CMS is "open for business," Jensen said during the panel discussion, "but it has slowed down quite a bit."
Since March 15, the agency had received 54 applications for coverage related to investigational device exemption studies, versus 48 over the same period in 2019, Jensen said. While this year's number reflects higher interest, it's taking longer to recruit for, enroll and finish these trials.
CMS' focus in being flexible during the pandemic has centered more around enforcement of coverage decisions, or lack thereof, Jensen said. For example, the agency opted to suspend national coverage determinations for certain respiratory devices, giving physicians more leeway to make decisions.
On the heart devices front, CMS is temporarily waiving volume requirements at centers performing transcatheter aortic valve replacement or mitral valve repair procedures, so sites don't have to meet previously required case levels to receive reimbursement. It's taking the same approach to percutaneous left atrial appendage closure and ventricular assist device procedures.
Clarification: Language in this story has been updated to better reflect that not all companies' clinical trial delays have led to product delays.