Patients need remote clinical trial options

Paradigm Shift

Decentralized clinical trials (DCT) are studies “executed through telemedicine and mobile/local healthcare providers, using processes and technologies differing from the traditional clinical trial model.” Remote decentralized clinical trials (RDCT) are “an operational strategy for technology-enhanced clinical trials that are more accessible to [participants] by moving clinical trial activities to more local settings.” Technology, which makes such clinical trials possible, was especially useful during the pandemic.

Participant-centricity needs to be foremost in defining and shaping the relative impact of a clinical trial. Participants avoid the inconvenience of traveling to traditional sites with the same frequency and engage from their home or preferred location.

In a blog on www.acrpnet, the website of the Association of Clinical Research Professionals, Harsha Rajasimha, founder and CEO of Jeeva Informatics Solutions, stated, “It’s not reasonable, ethical or fair to expect patients to go to a physical site when it’s not necessary for the conduct of a clinical trial.”

He added, “Doing so puts an unfair burden on patients, caregivers and even clinical trial practitioners. If we are serious about patient centricity, it begins with giving patients choice in how trials are conducted and building that [input] into the protocol design at the earliest stages…not as an afterthought.”

Jeeva Informatics Solutions (Jeeva), a seed-stage start-up, has the mission of developing artificial intelligence (AI)-driven decentralized clinical trials and optimizing patient-focused clinical research. According to Jeeva’s website, the Jeeva Trials solution reduces patient travel burden by replacing in-person trial site visits with videoconferencing, remote data collection and digital engagement.

Jeeva has claimed that it is particularly beneficial for both rare disorders and clinical research studies involving long-term follow-ups and safety monitoring. The company is a member of numerous life science membership organizations, including Virginia BIO, BioHealth Capital Region and the Global Genes Corporate Alliance.

Effective, patient-driven protocol design “minimizes the burden on patients to participate in a study,” Rajasimha explained. “We’ve been expecting for far too long that patients will go to a brick-and-mortar clinic” for every clinical trial interaction.”

Praising what he described as a “paradigm shift” in acceptance and usage of elements of decentralized clinical trials (DCTs), Rajasimha said, “For 70 years we’ve been doing clinical trials in much the same way, but now we’re seeing a revolution in the form of patient centricity. DCTs are 100 percent here to stay.”

In fact, Rajasimha said that he expects their usage to increase in the coming years. “Early adopters” are driving usage now, and there’s been a “bell curve” of acceptance, just as is often witnessed in the evolution of any new technology, he noted.

On the other hand, Rajasimha explained that he agreed that DCTs are not designed to work in every situation. “Decentralization is not the goal; it is a means to an end” to give patients additional options, he added. “In some cases, [DCTs] aren’t an option. Some people also just like in-person visits even” when they aren’t strictly necessary, according to Rajasimha. “We’re not replacing all trials with remote visits.”

However, “when there’s an opportunity to leverage remote options to help patients, we should examine  it closely,” Rajasimha concluded.