Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, share how their newly formed collaboration is reshaping the clinical trial process using data, helping to reduce costs and allowing for the assessment of broader patient populations.

AppliedVR and Komodo Health Collaborate to Conduct Clinical Trial Using First FDA-Cleared Virtual Reality (VR) Platform and Large Datasets to Examine Key Endpoints of Chronic Pain Intensity and pain interference.

“We have before us an incredible opportunity to have much faster validation of new therapies across all treatment modalities, to massively accelerate clinical trial design and recruitment, to increase representation and equity in and most importantly, to achieve better patient outcomes and save healthcare system time and money,” says Sun.

Many companies are realizing that traditional clinical trial processes need to be changed to improve efficiency, and partnerships are forming in different ways to assess how digital therapies, such as virtual reality, can improve drug design and outcomes. trials.

Separate offers

AppliedVR creates virtual reality-based treatments aimed at relieving chronic pain. The company has developed the first FDA-cleared home VR pain treatment, RelieVRx, indicated as an adjunctive therapy for chronic lower back pain.

Meanwhile, Komodo Health holds its “health map,” providing anonymized patient journeys of more than 330 million patients through their encounters within the healthcare system for more than five years.

The partnership came about after AppliedVR aspired to perform a clinical trial on the effectiveness of RelieVRx using real patient experiences and specific datasets.

Sackman sought to examine medication taking and the patient journey and how RelieVRx influences this. He says the company needed to find a partner who could help it achieve these goals.

“Many companies make big claims about how you could use real-world data and large claims datasets, but as you start to unpack what that means, many companies are acquiring the same data, which tends to be open data, not closed data,” Sackman says.

Sun says Komodo is keen to drive the adoption of new processing modalities, primarily because they align with Komodo’s thesis of “the key benefits of bringing together two cloud-native, digitally-focused companies from one way that benefits patients.

Each with their individual and specialized offerings, both companies are preparing to conduct clinical trials using their strengths – essentially overhauling the way clinical trials are conducted using technology.

The study

AppliedVR and Komodo Health will conduct multiple health economic outcome research studies using a method that Sackman says will allow companies to shape the speed, quality and design of trials.

To start, the companies will run a 1,000-person randomized controlled trial that will include four arms and last 16 weeks in total.

Participants will be divided into two groups during the first eight weeks: the control group (dummy comparator) and the active treatment group, which will receive AppliedVR’s RelieVRx device.

“In addition to understanding the results during the primary treatment period (the eight weeks of treatment), we also look beyond that and say: what happens when a patient stays on treatment for another eight weeks? ?” Sackman said.

Half of the participants in each group, the sham and those receiving the RelieVRx device, will continue to be monitored for an additional eight weeks to assess this issue.

“The goal is to look at key endpoints of pain intensity and pain interference, but we are also looking to fill additional clinical and economic gaps to understand the true value of our product. in health care,” says Sackman.

The study will look at several mood indicators, such as depression, clinically. Researchers will also assess physical function, both subjective, through traditional pain scores and patient-reported outcomes.

“We can couple that with claims data and look directly at healthcare resource utilization and see which doctors patients are seeing and whether they’re going to the ER or urgent care because of pain,” says Sackman.

Researchers will also look at what medications participants are taking and whether that changes due to AppliedVR’s program.

“We want it to represent how patients will use RelieVRx in the real world, so that we’re not artificially restricting the use of drugs or any other medical treatment,” Sackman says. “But we are trying to figure that out. We collect this information and review this data in Komodo’s system.

Deeper use of data

The study will also consist of a synthetic control arm, which will assess how the cohorts compare to a patient with average pain.

“We’re looking to make sure we have balanced cohorts, and we can assess those things in the initial matching phase of the study, but we also know that pain is incredibly complex,” Sackman says. “There is no miracle solution that works for 100% of patients.”

Pain treatment often requires many different therapies, and many patients do not have access to interdisciplinary or integrated pain treatment.

Ultimately, a different combination of therapies will work for a given patient.

Using health data from Komodo will provide a broader picture of the broader pain patient population, allowing for a better understanding of the effectiveness of RelieVRx in the real world.

Sun says there are so many dimensions to how Komodo data will enrich the trial, including reducing costs, making the process of doing clinical trials easier, and reducing existing health disparities and health inequalities.

“This type of approach offers the opportunity to reduce trial design costs that reduce visits, supplies, equipment, clinical procedures, etc. related to the study. your feasibility analysis and reviewing the inclusion/exclusion criteria,” says Sun.

“Even so, almost 90% of phase 3 studies are still not recruiting. Even when they register, they don’t register on time. Finally, most clinical studies today do not take into account under-represented patient populations. When you run studies that don’t take that into account, you’re endorsing therapies that don’t take that into account. You are only exacerbating these existing systemic health equity challenges.

The partners point out that this new approach, coupled with “the explosion in the availability and accessibility of real-world data and evidence”, as Sun states, creates an opportunity to use this new technique to complement evidence. traditionally generated by clinical trials. control groups.

“We expect to see device and pharma companies start thinking about the decentralized models of today – increasing patient access, accelerating study recruitment and completion, and empowering patients to have more ownership and access to clinical trials,” Sackman said.

“This is just a remarkable change in the culture of conducting clinical trials. These trends will start to show up in larger companies, which are a bit more resistant to change due to risk, and that’s understandable, but I think you’ll see a lot more of these companies following this playbook over the next decade.

About the interviewees

Web Sun is co-founder and president of Komodo Health. He oversees operations, including business development, sales and marketing, and people. He is also an Executive Advisor for Reify Health, Heads Up Health™ and other healthcare/healthtech start-ups focused on big data, SaaS, health IT (HIT) and predictive analytics. to improve patient outcomes.

Josh Sackman is president and co-founder of AppliedVR, a digital therapy company enabling remote pain treatment through prescription virtual reality (VRx) therapy. It was his own experience of pain, anxiety and isolation as a pediatric patient that inspired him to make chronic pain more manageable for others. After earning a business degree from USC, Sackman completed a bilingual MBA at IAE Business School in Buenos Aires, Argentina. He then built a career in digital marketing focusing on the fitness industry, eventually taking on the role of CEO at Cycle House, a boutique fitness company. He is a frequent guest speaker at international conferences.

About the Author

Jessica Hagen is a freelance health and life sciences writer and project manager who has worked with medical extended reality (XR) companies, fiction/non-fiction writers, non-profit organizations and at profit and government entities.