SAN FRANCISCO and ARLINGTON, VA, October 5, 2021—Curebase, a company committed to democratizing access to clinical studies, and the Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, today announced a research and education partnership designed to help digital therapeutics (DTx) organizations conduct effective clinical trials.
In the first phase of the partnership, Curebase and DTA will develop a joint white paper that will:
-Outline how much and what kind of evidence is needed for regulatory bodies and public and private health insurers across nine countries across North America, Europe, and the Asia-Pacific region to adopt DTx
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-Establish best practices for clinical trial design and execution for digital therapeutics (with input from DTA members) that would generate the evidence required for specific regulatory bodies and payors
The partnership is part of DTA's recently announced Resource Partner Program, an initiative to accelerate the development and post-launch success of clinically evaluated DTx by building a best-in-class network of commercialization and product development service providers. DTA Resource Partners are rigorously screened and vetted in order to collaborate with members of the Alliance, which include digital therapeutics companies, medical device companies, non-profits, research organizations, and pharmaceutical manufacturers.
DTx products deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad range of diseases and disorders. Examples of DTx products include a mobile app that helps users with diabetes manage their condition and daily activities through "coaching" messages, and an online program for people struggling with depression that utilizes cognitive behavioral therapy-based techniques, including artificial intelligence to help patients break negative thought loops and behavior patterns.
"We're excited to partner with DTA and work with its members to define clinical trial evidence requirements, ensure their trials are running in a way that's compliant, and get their products out to the market faster," said Adam Samson, senior director of clinical operations and customer success at Curebase. "This partnership gives Curebase an opportunity to share its unique experiences in running DTx studies, and pay some of that forward to DTA members."