Thanks in large part to COVID-19, decentralized clinical trial technology is having its moment in the sun.
Even in the clinical trial area, which typically operates with a fear of change, experts talk of discernible excitement over the potential of decentralized clinical trial technology.
“The silver lining of the pandemic is that we were forced to undergo more innovative approaches to research, and in fact, we found out that the sky didn't fall,” said Dr. Jeff Kingsley, CEO of Centricity Research, a clinical research organization. “It was fine.”
Investments in the technology are on the rise. According to Digital Health Business & Technology’s database, there were five deals for companies that offer decentralized clinical technology in the second quarter of 2022, compared with four in Q1, three in Q4 2021 and none in Q3 of last year. The category has seen $534 million in funding in the last year.
“Venture capitalists have put their money on the line,” Kingsley said. “That's good. That's going to force us to seek innovation and get results faster than we ever did in the past.”
Medable, a company that offers a clinical trial platform for pharma companies and research organizations, benefited the most from this interest when it received a $304 million funding round in October 2021. The company has received three separate funding rounds since COVID-19 entered the picture in early 2020. Michelle Longmire, the company’s founder and CEO, said COVID-19 showed the value of decentralized clinical technology and virtual clinical trials.
“What’s been exciting is that decentralized clinical trials has become a category of its own in the last few years,” Longmire said. “The adoption of decentralized clinical trials played a significant role in the development of critical vaccines during COVID.”
Shawn Tedman, vice president of biopharma innovation at ixlayer, a clinical testing technology company, has seen an increasing interest in the technology as well.
“I’ve been on the edges of decentralized clinical trial technology for the past 8-10 years and it’s moved at a glacial pace,” Tedman said. “COVID opened the floodgates and they aren’t going to be closed any time soon.”
Cost and diversity
Retailers, such as Walgreens and CVS Health, have also entered the fray, along with large clinical laboratory companies like Laboratory Corporation of America. Walgreens launched a clinical trial business in June, saying it would use a decentralized clinical trial platform and in-person locations to recruit for and conduct clinical trials. CVS Health launched a clinical trial division in May 2021, and in February said it was teaming with Medable for a virtual component.
“For ages, clinical trials have not been very patient-centric,” said Josh Rose, CVS’s head of decentralized clinical trials. “They were typically done at academic medical centers or research sites that are far away from the communities they serve. They were done in a very manual way in brick-and-mortar settings. Because of that, it was challenging for patients to participate.”
According to a study published in Perspectives in Clinical Research, 80% of trials fail to enroll patients on time, resulting in an extension of study and or addition of new study sites. Data from the Tufts Center for the Study of Drug Development said that up to 50% of trials are not completed because of insufficient enrollment. Those who favor decentralized clinical trials say that the technology can speed up the enrollment process and result in cost savings for pharma companies and research organizations.
“The return on investment is real,” Longmire said. “We’re all facing inflation and wondering how we can get more out of our current resources. That’s why decentralized clinical trials has become a critical strategy in the timelines of many executives in research and pharma.”
Longmire said that decentralized clinical trials are on average five times cheaper to run than regular clinical trials in Phase II studies, citing research from the Tufts Center for the Study of Drug Development, Tufts University School of Medicine and its own database.
But it’s not just a financial benefit to research organizations and pharma companies, Kingsley said. He said increased adoption of virtualized clinical trials will ultimately speed up the Food and Drug Administration’s approval process and get therapeutics to patients faster.
Rose said the technology will also allow stakeholders to get a more accurate demographics. Stanford University and Boston-based Massachusetts General Hospital researchers found that 80% of clinical research conducted use white participants.
“The beauty of both the technology and community-based clinical research is you're able to bring in a representation of patients that aligns with the area’s true demographics,” Rose said.
Fear of change still strong
Rose said that in the year since CVS Health launched its clinical trial division the company has participated in 20 different COVID-related studies. The biggest challenge, he said, is that the fourth biggest company on the Fortune 500 moves purposefully slowly, to be compliant with privacy and patient protections.
“I would say that CVS tends to be a very conservative organization because of who we are in the industry and that is not good for speed,” Rose said. He also said that the industry is still slow to break from the traditional model of clinical research. “Getting people to overcome the traditional mindset has been a little bit of a hurdle.”
Kingsley has seen this challenge as well. He said that fear is what’s holding back companies from further adopting decentralized clinical trial technology. He used the example of clinical pediatric research, an area where the FDA has been pushing for more enrollment.
“Every parent wants to know that their son or daughter is getting something that was researched well,” Kingsley said. “Any parent would say, ‘Of course there should be more pediatric research, but just not on my kid.’ Similarly, the industry will say, ‘Of course we need to move trials to the patient, just not on my trial. I’ve got this budget and I need this to be successful keep my job.’ It’s scary to be the one to take the gamble on [decentralized clinical trials].”
Tedman said it’s not just the industry that may be hesitant to accept virtualized clinical trials. He said patients themselves may be hesitant to participate if they aren’t fully informed and engaged by the research organization or pharma company. Despite SUCH lingering hesitation, he is confident about the technology’s potential.
“There is something like 1,300 decentralized trials that are supposed to get started this year. I think that’s up 20% or 25% from last year,” Tedman said. “I think the balance has shifted, where the default is, ‘Let's see if there is any way that we can decentralize parts of this trial’ rather than the default being the traditional mode. That’s huge progress.”
More information: Perspectives in Clinical Research study