Decentralizing Clinical Trials Through Disruption

By Matt Phillion

Clinical trials are expensive, take significant time, and can run into any number of challenges and delays. The average drug study will see a 30% patient dropout rate. What is needed, according to Virginia-based Jeeva Informatics, is more diverse patient enrollment, better engagement, and increased evidence generation. Jeeva is helping organizations move through clinical trials more smoothly and quickly via a browser-enabled mobile device that helps facilitate all of the above.

“We’ve interviewed 2,000 to 3,000 customers and stakeholders over the past few years, and we often hear: Why does it take 10 to 12 years to get one drug to market? Why does it cost $2.5 billion to get through the process?” says Harsha Rajasimha, PhD, founder of Jeeva Informatics. “What we’ve heard through the years is that patient recruitment is one of the biggest bottlenecks.”

There’s a variety of reasons for that, Rajasimha says. For one, the traditional approach to clinical trial recruitment has grappled with the same limitation for 70 years: in-person, face-to-face interactions between clinical investigators, requiring patients to visit them in person.

Additionally, clinical trials aren’t always offered to all the patients who are eligible, he says. “It’s too restrictive, limiting to patients who live within a 50-mile radius of the brick-and-mortar sites,” says Rajasimha. “Less than 3% of the patient population, even when we’re discussing cancer, have a chance of learning about a clinical trial, let alone participate.”

The COVID-19 pandemic, of course, has worsened these issues. Today, “85% of all clinical trials are delayed by 30 days or longer, and others are terminated because of poor involvement,” says Rajasimha. “Every day a trial gets delayed can cost not just lives, but also dollars from sponsors or from potential lost revenue.”

This can mean millions or even billions in lost costs. “It’s a huge public health issue, but it’s also a financial and R&D bottleneck for the industry,” says Rajasimha.

At the core of recruitment

Clinical trial recruitment issues boil down to two major challenges, says Rajasimha.

“The first is identifying the right patients who meet the critical requirements for the trial,” he says. A clinical trial may have complex inclusion and exclusion criteria that aren’t always outlined in one centralized location, making it difficult to accurately identify and select eligible patients.

The second issue is educating patients on the trial itself. “There are requirements that patients are educated about the clinical study, the risks, the benefits,” says Rajasimha. This generally involves an informed consent process where the patient meets with the clinical investigator in a closed room. The attendant time and location limitations can be a stumbling block for recruitment, and they were especially troublesome during the pandemic.

“Many clinical trials had to be put on hold, so continuation of the trials was a challenge. Patients were not willing to go into the clinic,” says Rajasimha. “The other part adding to the difficulties of these trials were on-and-off travel restrictions. Patients who might have been visiting the clinic might go a month or two or more between visits.”

When patients are unable to fulfill their requirements, the data in a clinical trial is compromised, Rajasimha notes.

“Continuity and integrity became a challenge during the last couple of years,” he says. “And the overall challenge remains the same: recruitment and keeping patients for the duration of the trial so we have complete and accurate evidence about its safety and efficacy.”

A disruption doubly needed

With the need for a more diverse patient population and better recruitment and retention, clinical trials were already primed for disruption, Rajasimha says. But COVID-19 brought the topic to the forefront.

“The solutions existed pre-pandemic already,” he says. “Remote informed consent existed, but the adoption rate was very slow. Because of the pandemic, though, willingness to adopt significantly accelerated.”

Decentralized approaches, like remotely obtaining patient data and remotely conducting clinical assessments, had been around for years, but it took a sea change in the industry to see their adoption take a huge step forward. “Many experts say we’ve achieved six to 10 years of acceleration driven by the pandemic,” says Rajasimha.

Jeeva asked the question: Where was the biggest need related to clinical trials in a pandemic era? Was it informed consent? Or telemedicine visits?

“What we figured out was that all these tools existed a la carte, but the challenge was that sites were overly burdened by needing six or more tools to make it all work,” he says. “The tools needed to talk to each other, and the data needed to be consolidated. This is a significant burden on site staff, who need to learn about each new tool, and then the CRO or sponsor need to integrate them on a clinical trial basis.”

Jeeva wanted to bring these tools together into a single login to make it easier for coordinators to deploy them.

This consolidation of workloads had a few benefits. “For one, we increased our target population from the 3% living within a 50-mile radius of a high-density metropolitan area to everyone on the internet,” says Rajasimha. “In the U.S., 82% of the population is online—it’s an order of magnitude above those living close to those cities and offers access for patients anywhere to those clinical trials.” While some travel is still necessary, much of the activity required for participation can now be done remotely.

Workload consolidation also expanded the reach of trials to underserved populations. “Clinical trials often have an underrepresentation of minorities, and minorities are often less likely to go into major academic medical centers to seek care—they’re more likely to go to a community or neighborhood clinic,” says Rajasimha. “And that means they are less likely to be offered a clinical trial.”

This expansion of reach doesn’t guarantee diversity, Rajasimha says, but it provides a chance to connect with not just people of color, but also anyone who lives in an underserved region or geographic area, he says.

Beyond improved patient access, consolidation of clinical trial tools has helped reduce burden on the staff members who conduct the trial. “We often think of things as patient-centric, but the staff take on a huge burden to make things easier for the patients,” says Rajasimha. “If we can enable them with simple tools all in one place rather than requiring multiple logins to multiple tools, that minimizes site burden.”

Even though the industry has been doing clinical trials for nearly 100 years, says Rajasimha, every new trial feels like the first one as each trial must optimize site selection, tackle patient recruitment, address risks, and examine historical data—much of which isn’t publicly available. Jeeva’s attempt at bringing such tasks under one browser-based roof offers publicly available information, but on a more granular level.

Barriers and wins

Rajasimha notes that while interest in clinical trials is on the rise, the industry hasn’t always had the right carrots and sticks to make the changes needed to improve reach and diversity.

“Sponsors are focused on getting through the trials process. Everyone wants to do the right thing, but they may ask, does it make sense to delay the trial for diversity? It requires a willingness at the board level, the leadership level, and senior management level, but also needs regulators to provide more guidelines and mandates,” says Rajasimha.

The FDA has recently made moves toward incentivizing patient diversity, and with the availability of convenient technology platforms, there’s even less excuse for sponsors to avoid doing so, he says.

Regardless of how technology might unlock the potential of clinical trials, ensuring patient safety and comprehension during the informed consent process remains paramount.

“It’s not rocket science, but it is human science—making sure we’re still complying with all the ethical practices, using good clinical practices, and that your research is valid whether you’re using centralized or decentralized processes. That doesn’t change,” says Rajasimha. “It’s very important to deploy the technology in the right way. Patients come in with varying levels of comprehension and different backgrounds.”

Overcoming those challenges early in the process will help down the line, he says.

“As long as we’re not addressing that upfront bottleneck obtaining proper informed consent, whether remotely or in person, we cannot truly realize the benefits of decentralized trials,” says Rajasimha. “The devil is in the details, and we need to work hand in glove with researchers and patients to make sure all concerns are addressed and all issues are brought to our attention.”

Matt Phillion is a freelance writer covering healthcare, cybersecurity, and more. He can be reached at matthew.phillion@gmail.com.