Use of landscape re-evaluation technology in clinical trials –

Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, report on how their newly formed collaboration is changing the clinical trial process by using data, helping reduce costs and assessing wider patient populations.

AppliedVR and Komodo Health are collaborating to conduct a clinical trial using the first FDA-approved Virtual Reality (VR) platform and extensive datasets to examine the main endpoints of chronic pain intensity and pain interference.

“We have an incredible opportunity to have much faster validation of new therapies in all treatment modalities, to significantly accelerate the design of clinical trials and enrollment, to increase representation and health justice and, most importantly, to achieve better results for patients and save healthcare system time and money, ”says Sun.

Many companies are realizing that traditional clinical trial processes need to be modified to improve effectiveness, and partnerships are being formed in various ways to assess how digital therapists, such as VR, can improve design and test results.

Various suggestions

AppliedVR creates VR-based treatments aimed at relieving chronic pain. The company has developed the first FDA VR-approved treatment for pain at home, RelieVRx, listed as an adjunct treatment for chronic lower back pain.

Meanwhile, Komodo Health maintains its Healthcare Card, which provides anonymous travel to patients of more than 330 million patients during their meetings within the healthcare system for more than five years.

The partnership arose after AppliedVR sought to conduct a clinical trial of the effectiveness of RelieVRx, using real-world patient experience and specific datasets.

Sackman tried to study the patient’s medication intake and travel and how RelieVRx affects this. He says the company needs to find a partner to help it achieve these goals.

“Several companies are making big claims about how you could use real data and data sets for large claims, but when you start unpacking what that means, many companies acquire the same data, which is usually open data, not closed data. “Sackman said.

Sun, for his part, says Komodo seeks to encourage the adoption of new treatments, mainly because it meets Komodo’s thesis that “the main benefits of merging two cloud-based companies, first digital companies, in a way that is from benefit to patients’.

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

Learning

AppliedVR and Komodo Health will conduct several studies on economic health outcomes, using a method that Sackman says will allow companies to shape the speed, quality and design of the tests.

To begin with, the companies will conduct a randomized controlled trial of 1,000 people, which will consist of four arms and will last a total of 16 weeks.

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

“In addition to understanding the results during the initial treatment period (eight weeks of treatment), we also look beyond that and say, ‘What happens when a patient stays in therapy for another eight weeks?'” Sackman said.

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

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

The study will look at several indicators of mood, such as depression, clinically. Researchers will also evaluate physical function as subjective, through traditional pain outcomes and outcomes reported by patients.

“We can combine this with claims data and look directly at the use of health resources and see which doctors visit patients and whether they go to the emergency department or emergency care because of pain,” Sackman said.

Researchers will also look at what medications participants are taking and whether this is changing as a result of the AppliedVR program.

“We want this to show how patients will use RelieVRx in the real world, so we don’t artificially restrict the use of drugs or other medical treatments,” explains Sackman. “But we are looking to find out. We collect this information and review this data in the Komodo system.

Deeper use of data

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

“We want to make sure we have balanced cohorts, and we can evaluate these things in the initial phase of a study, but we also know that the pain is incredibly complex,” Sackman said. “There is no silver bullet 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 each patient.

Using Komodo’s health data will provide a bigger picture of the wider population of pain patients, allowing for a better understanding of how effective RelieVRx is in the real world.

Sun says there are so many dimensions to how Komodo data will enrich the trial, namely in reducing costs, facilitating the clinical trial process and reducing existing health disparities and health inequalities.

This type of approach offers the opportunity to reduce the cost of designing studies that reduce study-related visits, consumables, equipment, clinical procedures, etc. your feasibility analysis and consideration of inclusion / exclusion criteria, ”says Sun.

“However, almost 90% of the phase 3 studies are still unrecorded. Even when they are recorded, they are not recorded on time. Finally, most clinical trials today do not report underrepresented patient populations. When you do research that doesn’t take this into account, you approve therapies that don’t take it into account. You are simply exacerbating these existing systemic challenges to health equity. “

The partners emphasize that this new approach, combined with the “explosion in the availability and accessibility of real-world data and real-world evidence”, as Sun says, makes it possible to use this new technique to complement evidence traditionally generated by clinical trials. control groups.

“We expect to see device and pharmaceutical companies begin to consider current decentralized models – increasing access to patients, increasing the speed of recruiting and completing studies, and empowering patients to have more ownership and access to clinical trials,” he said. Sakman.

“It’s just a remarkable change in the culture of clinical trials. These trends will begin to manifest themselves in larger companies that are a little more resilient to change due to risk, and that’s understandable, but I think you’ll see a lot more of these companies follow this book over the next decade.

About the interviewees

Web Sun is the co-founder and president of Komodo Health. He oversees operations, including business development, sales and marketing, as well as people. He also serves as an executive advisor to Reify Health, Heads Up Health ™ and other healthcare / healthcare technology-focused startups, SaaS, Health IT (HIT) and predictive analytics to improve patient outcomes.

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

About the author

Jessica HagenJessica Hagen is a freelance writer in life sciences and healthcare and a project manager who has worked with augmented reality (XR) companies, authors of fiction / nonfiction, non-profit organizations and non-profit organizations. and government organizations.

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