Executing a clinical trial takes, among many things, willing participants and a patience for sticking with what could be years of data collection.
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COVID-19, however, threw a wrench in the traditional method of clinical trials, in which participants usually travel to a clinical site for an in-person evaluation. This is causing principal investigators and research staff to find other ways to keep participants connected with studies.
Some startups, including Medable and Unlearn.AI, are working to fix the problems facing clinical trials, from recruiting enough patients to moving toward more virtual aspects. Both received investments within the past few months to help reach those goals.
Even before the pandemic, some in the clinical trials sector were pushing for the addition of virtual components, such as wearables for data collection throughout the day. Others sought the adoption of decentralized clinical trials, those executed through telemedicine and mobile or local health care providers.
“Pre-COVID-19, some people believed in what we were doing,” Science 37’s chief medical officer, Dr. Jonathan Cotliar, told Crunchbase News. “There were early adopters and skeptics and everyone in between. Today, we have seen an exponential explosion of market adoption.”
Los Angeles-based Science 37’s platform supports virtual or decentralized trials, helping to enroll patients and keep them engaged in the trials.
Although his mission is to show people how easy it is to do remote clinical trials, there was a surreal aspect to the adoption, Cotliar said.
“The amount of opportunity we have seen, even in verbal deals, was honestly unexpected,” he added. “We had been trying to convince people, and now they are doing it because there is no other real solution.”
Aiding in the adoption were new guidelines from the government, Cotliar said. In March, the U.S. Food and Drug Administration provided recommendations such as phone contact, virtual visits and “additional safety monitoring for those trial participants who may no longer have access to investigational products or the investigational site.” Meanwhile, the Centers for Medicare and Medicaid Services relaxed its reimbursement rates for telemedicine visits.
The right fit
As of May 15, the U.S. National Library of Medicine’s ClinicalTrials.gov site listed about 300,000 global research studies, including 1,500 related to COVID-19. Experts say 55,000 clinical trials are actively enrolling and providing care for participants worldwide right now.
Alison Holland, head of decentralized and remote trials at Palo Alto, California-based Medable, has more than 30 years of clinical trial experience. Prior to working at Medable, Holland managed more than 300 clinical trials while an executive at Princeton, New Jersey-based clinical research organization Covance.
She said she would like to see clinical trials have the same offerings as, for example, ordering food.
“You might want to go to a restaurant, carry out, pick something up on the way home or have food delivered to your home,” Holland said. “If you give people different options, they will appreciate the convenience of doing it remotely. The key is you want to have relatable data, so you have to plan up front.”
In the clinical trial world, this means that a group of trials will still need to be on-site—especially those in which toxic compounds are administered—one group could go totally virtual and the last group could be a hybrid of the two, she said.
One of the areas Holland said would be best suited to introduce virtual components is the big-scale oncology trials that involve a long-term follow-up. This would allow the participant time at home to recover, but have effective oversight. Other trials, such as dermatology, as well as patients with Alzheimer’s, Parkinson’s disease or schizophrenia, may also benefit from a more comfortable experience at home, she added.
A more comfortable experience may also inspire participants to volunteer for clinical trials in the first place. During COVID, finding participants has become harder, said Wout Brusselaers, founder and CEO of Deep 6 AI.
“The real impact right now with COVID is that a lot of the big trial sites, and some smaller ones, are having to blend virtual with on-site,” Brusselaers said. “The key goal is make sure your organization has all of the tools to be ‘crisis robust,’ where you have to minimize the face-to-face, but also be selective on who is in the trial.”
The Pasadena, California-based company provides clinical trials acceleration software and raised a $17 million Series A round last November for accelerating and optimizing clinical trial design, recruitment and management.
The process of evaluating patients is time-consuming, Brusselaers said. As a result, more than 85 percent of trials are delayed and even fail due to poor recruitment, he added.
While virtual clinical trials may attract a more diverse subset of participants, without some sort of consistent “face time,” it may prove difficult to keep those participants, Brusselaers said.
“For patients, especially with those with certain backgrounds, there really is a benefit to having that trusted doctor,” he said. “Without physicians it is hard. In addition, they might not be tech savvy or even language savvy, so having community advocates work with health care professionals to help them navigate through it would make clinical trials more accessible.”
Incorporating local resources
In the quest to create a hybrid model, some clinical site operators are tapping into local resources, where the participants live, to manage certain aspects of the trial in an effort to keep them engaged.
Amanda Rangel, senior vice president of business development for VirTrial, said she has seen pretty much all reasons for why patients don’t stick with a clinical trial. The Scottsdale, Arizona-based company helps pharmaceutical companies conduct clinical trials and enables research sites to improve their patient recruitment and retention.
“It could be the time required and distance they have to travel to the research sites,” Rangel said. “People have to work and have children, so they may have to take time off of work or find day care. It can be very burdensome on their life.”
Even adding technology as a component of the clinical trial can sometimes affect participants’ willingness to comply, she said. For example, one of Rangel’s participants told her that one of the technology items kept beeping so much that they put it in the car trunk.
Overall, VirTrial aims to bridge the gap between using a clinical site and conducting trials remotely.
“Instead of revolving around a site, we can move it into patient homes,” Rangel said. “Our approach has been that complex procedures, like MRIs, will still be a requirement, but where can we be creative?”
She said certain things, such as blood draws, can be done at a local clinic, while remotely connected devices can be used to provide weight and vital signs. In addition, VirTrial often uses home health nurses who can go to the participant, she added.
Meanwhile, all of the experts say adding some component of decentralized clinical trials could help revolutionize the industry, help keep clinical trials going amid COVID-19, and even create an opportunity for trials that address the 7,000 rare diseases with no therapies on the market.
“When you think about those unmet conditions, people may fly hundreds of miles to have access to treatment because they have no other choice,” Holland said. “By making the studies accessible, it opens up a world for other people.”
Blogroll Illustration: Li-Anne Dias