Industry experts agree that 100 percent virtual trials won’t work for all types of studies, but they predict that by 2025, all trials will have at least some virtual component that offers flexibility in how sites interact with participants and makes trials more accessible and more appealing to the public.

“Patient-centricity is the key thing,” says Encore Research Group CEO Michael Koren. “If a patient wants to do a FaceTime call and make that their visit, great. If a patient wants to come in and do that visit because they perceive that as part of the value proposition, that should be their choice and preference,” he told attendees at the 2020 MAGI Clinical Research vConference last week. 

Koren said some people think of clinical trials as something of a concierge service. “It’s above and beyond what they’re getting in healthcare, and they like the nurturing, they like to come in and have that human interaction.” Other participants appreciate the convenience of being able to participate in trials without leaving home, especially during the pandemic.

A new report by the Tufts Center for the Study of Drug Development (CSDD) shows that participants in trials that use some kind of patient-centric method, such as telemedicine visits or wearable devices, are more satisfied with their trial experience than those who take part in more traditional trials. According to a recent survey by the Center for Information and Study on Clinical Research Participation, among the 42 percent of trial participants who have used telemedicine visits in 2020, the satisfaction rate was 19 percentage points higher; the 67 percent of participants that have used text messaging in trials were 14 percentage points higher, and the 21 percent using smartphones and wearable devices were 32 percentage points higher.

Telemedicine is the most popular method, CSDD says, with more than 80 percent of the 50 top pharma companies surveyed saying they use it in their trials “due largely to the relative speed and ease of implementation.” Thirty percent of respondents conduct home visits for assessments and procedures and just over 20 percent ship trial supplies directly to patients.

Only about 5 percent use wearables and other devices, most likely due to the longer lead time and infrastructure required, CSDD says. Still, more than half of respondents said such devices were either “very easy” or “easy” to use.

Andy Lee, senior vice president for global clinical trial operations at Merck, said the company is trying to move toward patient-centricity in its COVID-related trials. “But sterile environments are not often available at home, a lot of the supportive diagnostic testing and imaging is very complex, and some of the laboratory work requires very skilled acquisition of the sample,” Lee said, which means trials often end up duplicating data collection efforts at the clinical site and at the patient’s home. 

“It is no secret we had to be innovative, and the necessity drove ways to work differently — such as remote consenting, changing procedures and doing telehealth,” Lee said. “We also looked at shipping medications directly to patients’ homes and a variety of different ways to do remote monitoring.” 

To determine what types of technology and virtual components will best support a trial’s primary endpoints, Merck uses decision trees that allow the company to consider which choices will best ensure that data are valid, accurate, reliable and reproducible. 

“It’s the early days [of the pandemic], but we need to have confidence in what we’re doing,” he said. “I think with time we’ll see appropriate trials using much more decentralized processes, but for hospital-based specialty care, this is more of a fantasy than a reality.”

Barbara Bierer, faculty director at Brigham and Women’s Hospital (BWH) in Boston, said the pandemic has caused the various stakeholders — investigators, clinical trial sites, patient groups, CROs and pharmaceutical companies — “to appreciate and attain a level of flexibility in how we do and conduct our business. These flexibilities, if done correctly, do not inhibit data quality and in fact are very patient-centric.” She said BWH revised their protocols so in-person visits are “only for essential visits that cannot be done in another way.”

One issue that makes patient-centricity a challenge is participants’ fear of the technologies they have to use in virtual trials, but it isn’t technology that keeps some trials’ enrollments low, Koren said. Rather, there is limited interest in the type of research that some trials are offering. But that hasn’t been the case in the quest for a COVID-19 vaccine, according to Koren, who serves as a COVID-19 vaccine investigator.

“From the first day, we literally had people pouring in trying to be part of these studies,” he said. “But they tended to be older, white and more educated. And we had more difficulty attracting people who were of color, who were less educated and of lower economic strata, which brings up some very interesting questions.” Chief among those questions is whether virtualization could open trials up to groups that can’t access trials.

Ashish Atreja, chief innovation officer for the Icahn School of Medicine at Mount Sinai (ISMMS), told attendees that the school did a fair amount of virtual operation before the pandemic, especially for real-world evidence trials and phase 4 registries. He said ISMMS had partnered with the American Gastroenterology Association to virtually track 55 clinical trial sites participating in a national fecal transplant registry. “This allowed us to realize that not everything has to be completely virtual or completely manual. You can have a blended approach as well,” he said.

“There are some aspects that can be made virtual, and some trials — especially phase 4 registries — can be made completely decentralized. But in the next four to five years, or maybe earlier, I would be surprised to see any trial that does not have a virtual component.”

The technology already exists, Atreja said, adding that the Science 37 virtual trial platform is a “very patient-centric model [that is] trying to create a rubric for making it easy and convenient for participants to enroll, engage and give informed consent.” But he warned it takes years for new technology to permeate the clinical trials ecosystem. “It took 20 years for [electronic health records (EHRs)] to become mainstream,” he said. “There may be some trials which do not require FDA approval, especially phase 4 or real-world evidence, and those may become the ‘poster child’ for how all these technologies come together and empower patients. And then slowly, they will go to more regulated trials,” he said.

“One year from now, we’ll have all the [active pharmaceutical ingredient manufacturers], health systems and EHR vendors completely certified by June — they have to do it for the 21st Century Cures Act — which means patients will have ability to actually get access to records, including labs. In three years, we’ll actually have a framework where the patients will actually be using it. We can predict the trend is in the right direction toward decentralization, but we all agree we are not there yet. Even if the technology is completely there, there will be many specific scenarios, especially for regulated FDA trials, where complete virtualization and complete decentralization should not be the goal. Making it effective, efficient and patient-centric should be the goal and the North Star,” Atreja said.