The utilization of decentralized or virtual clinical trials soared last year due to the complexities of involving patients in clinical research trials during a pandemic, and that trend is expected to continue well into the future.
More than 80 percent of all ongoing studies have remote or decentralized elements—such as electronic diaries—says Rasmus Hogreffe, vice president of decentralized clinical trial innovation at Medable, a cloud platform for patient-centered drug development. The California-based tech startup secured $118 million in funding last year to accelerate digital and decentralized clinical trial adoption in the US.
Prior to the pandemic, decentralized trials were not popular, according to Craig Lipset, cochair of the recently-formed Decentralized Trials & Research Alliance (DTRA).
“The pandemic was a catalyst for change this past year, and I believe it accelerated the adoption of decentralized trials because there really was no other option,” says Christoph Koenen, executive vice president and chief medical officer at Otsuka Pharmaceutical in Princeton, New Jersey.
Otsuka, along with New York City-based Click Therapeutics, recently started enrolling the first fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with major depressive disorder (MDD) who are on antidepressant monotherapy. The randomized, controlled trial will enroll up to 540 patients nationwide.
Government regulators generally support decentralized trials, which bodes well for future growth. Last March, the FDA’s guidelines for conducting clinical trials during COVID-19 allowed alternative methods for assessments such as phone contacts or virtual visits.
Advantages of going virtual
There are numerous benefits of remote or virtual trials to both clinical research trial operators and patients, Hogreffe says.
Traditional clinical research trials can include 20 to 25 in-person visits per patient, he notes. Eliminating those in-person visits saves clinical research trial operators a tremendous amount of time and money.
Conversely, with virtual trials, participants can use their own devices to answer questions and input information. Smart watches, Fitbits, and other devices “can give insight into the participant that we didn’t have before,” Hogreffe says. They essentially serve as a “black box” of information on each patient.
Patients also typically feel more comfortable in their own homes. “Often, patients will have elevated blood pressure because they are going to a clinic,” says Hogreffe. Eliminating the in-person visit helps to “paint the real picture of the specific compound being tested,” he says.
Reporting of adverse events can also be more accurate when patients capture the data in real time on their own devices. "Let’s say there are three, four, or five weeks between clinic visits. How can you remember on day eight that you had a headache?” Hogreffe says.
Virtual trials can better tap into participating patients’ needs and preferences, as in-person clinic visits and assessment meetings can be difficult to schedule—particularly for those with health challenges.
“Decentralized trials lessen the burden and improve comfort and convenience for everyone who is participating,” Koenen says.
That may be especially true for children and the elderly, since their ability to attend in-person visits may be limited by their health conditions and/or ability to travel, according to Hogreffe.
Rapid growth of decentralized trials expected
Experts predict that the use of remote or virtual clinical trials will continue well into the future.
“I believe we are just beginning to see the tip of the iceberg when it comes to reimagining clinical trials,” Koenen says. “With remote trials’ numerous benefits, I think we will see continuous growth, especially since, by nature of it being virtual, you are breaking down geographic barriers and opening the door to access and diversity.”
Hogreffe believes the expansion of direct-to-patient lab testing and local testing facilities creates an ideal environment for decentralized lab collection within clinical trials. “Through partnership and integration, patients can seamlessly generate lab eRequisition forms or order kits sent directly to their home. This removes a tremendous amount of burden and can even eliminate some traditional site visits in favor of telemedicine plus labs.”
Of course, there will be a need for new ways to monitor the sample transfer chain and to ensure end-to-end data privacy and integrity, he says. “Accurate audit trails and full data provenance will be needed.”
While there is a heightened need for virtual or remote trials during the pandemic, they will continue well after the pandemic subsides so that clinical research operators can continue trials when there are other disruptions, such as patient health issues or weather disruptions, Lipset notes.
“Some of these tools that were viewed as somewhat risky in 2019 are now helping companies become risk adverse. We are starting to see pharma companies and others internally committed to using these approaches,” he adds.
Even though he helped design the first fully remote clinical trial 13 years ago as an executive with Pfizer, Lipset believes that a hybrid virtual/brick-and-mortar clinical trial model will prevail.
He says patients still desire an in-person component. “When we are listening to patients’ concerns around their barriers, the option of having a site nearby—the ability to go in when I have time or have a concern—is still wanted,” Lipset says.