Curebase to partner on VR-based chronic pain clinical trials
Curebase, a company offering decentralized trial software and support, has announced a collaboration with virtual reality company AppliedVR, aimed at testing the viability of using virtual reality (VR) therapy to treat chronic pain. During the one-year partnership, AppliedVR plans to deploy Curebase’s platform to conduct five different trials centered on VR therapy for pain patients.
Tom Lemberg, CEO and founder of Curebase, spoke with Outsourcing-Pharma about the firm’s decentralized trial solutions and the details of the chronic pain partnership with AppliedVR.
OSP: Could you please tell us a little bit about Curebase—who you are, what you do, key specialties, and what sets you apart from other companies in this arena?
TL: Curebase is a leading decentralized clinical research software platform and virtual site. The Curebase platform enables any patient and any healthcare provider to be part of a clinical study. This includes patients' own physicians, research naive providers in community settings, and telemedicine docs.
We are accelerating enrollment and enabling novel study designs with diverse populations virtually, and with community providers in underserved areas. Curebase has unique experience in digital therapeutics, which has become a large component of all current business. Curebase's unique integrations and APIs allow for digital therapeutics to connect and work together with Curebase's clinical workflow.
Additionally, Curebase has designed the platform for useability around study designs that digital therapeutics lean on. Curebase operates as a complete eClinical software platform and virtual research site that can be added to any study, ongoing or just getting started.
OSP: Please tell how you came to join up with AppliedVR on this project—did you connect through an event or association, have you worked together on previous projects, etc.?
TL: AppliedVR is committed to being the most evidence-based solution in healthcare and is currently working through its de novo FDA approval. However, the company is very interested in running many more studies to demonstrate both the effectiveness of its solution for treating chronic pain and its ability to lower costs.
So, AppliedVR reached out to Curebase earlier this year after hearing about all the work we have been doing in digital therapeutics. They sought to understand more about how our system uniquely adapted to digital therapeutic study designs and wanted a partner with this unique experience.
OSP: Please tell a bit about VR, and some of the ways it’s been used in general patient care, pain management specifically, and also clinical research.
TL: Virtual reality's use in healthcare has been growing significantly, and has been shown in multiple studies to be a powerful therapeutic for everything from reducing pain to treating anxiety. It's been used to help veterans deal with many healthcare challenges, including stress and anxiety.
AppliedVR has even deployed its treatments to help with the pain associated with childbirth and wound debridement for severe burn victims -- two of the most painful experiences that someone can face. Now, with the opioid crisis in America still a huge issue, AppliedVR is focusing on chronic pain via its EaseVRx solution, which is shown to be effective at reducing multiple pain indicators and can be a solid opioid-sparing treatment.
OSP: Could you tell us a bit about AppliedVR’s pain management platform, and why it’s a good fit for this project?
TL: AppliedVR has been a pioneer in advancing the next generation of digital medicine and has created multiple programs for treating both acute and chronic pain. Currently, its EaseVRx platform that's for treating chronic pain, which a Johns Hopkins study in the Journal of Pain found can cumulatively cost as high as $635 billion a year — more than the annual costs of cancer, heart disease, and diabetes — is its primary focus.
EaseVRx is an eight-week program that can be self-administered in the home, making it a great tool for people suffering from chronic pain. The solution recently received breakthrough device designation from the FDA, and the company expects to have its de novo approval soon.
Because it's meant for the remote treatment of pain, that necessitates a study design that replicates the intended use environment. That's why Curebase was the perfect fit for all AppliedVR's studies. Curebase enables remote research, so AppliedVR's product can be used as intended, by patients in a home setting.
OSP: Then, could you share a little more detail about what each partner is bringing to the table?
TL: Curebase's software platform and services will enable AppliedVR to conduct research studies more quickly and in any setting (home, community, etc.). This will allow AppliedVR to gain the necessary clinical data it requires to build a better body of evidence for both FDA approval and to get payers on board with reimbursement.
AppliedVR brings a deep understanding of user experience and clinical endpoints for VR therapy to tailor the most scientifically rigorous study designs that also have the highest degree of patient satisfaction.
OSP: Do you have anything else to add?
TL: We're excited for the future of this partnership and are looking forward to sharing the results of the studies in the near future. As digital medicine, and VR specifically, find more places to have a greater impact on health, the sky is unlimited for the category.
Digital therapeutics as a category are showing that not everyone needs a pharmacological intervention, and solutions like AppliedVR demonstrate that digital medicine can not only be effective at treating the most costly and complex health concerns, they also can be used just as easily as taking a pill.