Resource • Article
The Evolution of Digital Therapeutics and the Need for Clinical Evidence: Lessons Learned from DTx West 2020
The digital therapeutics industry is experiencing an evolution, one that is attracting innovative companies and savvy investors alike. DTx West 2020 was the ideal meeting place for more than 300 of these stakeholders as the event kicked off on February 18, 2020 in San Mateo, California.
Clinical Evidence is Key
Wayne Bowden, VP of Program Development at Biorasi, was on-hand to present “Clinical Trials for Digital Therapeutics: Evolution, Evidence, and Execution.” Bowden’s insights were part of the Method of Evidence Generation and Translation panel discussion moderated by Acacia Parks, Chief Scientist at Happify, a digital therapeutic leader in solutions for mental health and well-being.
“Clinical evidence was the most ubiquitous topic at DTx West,” said Bowden. “It was top of mind for all attendees. Evidence remains a critical asset in the development of digital therapeutics, and it is the one criterion that can separate your app from all the other health apps in online stores. Who is going to believe that your app works? How are you going to differentiate your company? Evidence is the key.”
The Importance of Regulatory Approval
But where do you draw the line as to what is enough evidence? That was a common question amongst the DTx West attendees, many of them noting a “gray area,” a wide spectrum of collected evidence that differs from product to product. Fortunately, there is a line already in place.
“Who decides how much clinical evidence is enough? That is the role of the FDA,” noted Bowden. “It is their role to draw the line and say, ‘this is the bar that your company has to cross.’ The established FDA regulated pathway proves the safety and effectiveness of your app.”
FDA regulatory approval offers digital therapeutic companies intrinsic value:
- Providing validation of the clinical evidence collected during the clinical trial
- Differentiating the company and the product from the competition
- Improving the marketability of your digital therapeutic to investors, patients, providers, and payers
“The FDA process is an objective measurement of evidence,” said Bowden. “That is what the digital therapeutic industry needs right now to continue its evolution.”
The Future of DTx
The Biorasi team enjoyed the chance to connect with our sponsors, colleagues, and new players at DTx West 2020, and we are looking forward to our next DTx event.
“I hope the takeaway from this event is that clinical evidence generation and FDA approval guidelines become accepted by more and more stakeholders,” said Bowden. “I am very much looking forward to DTx East in September, and I hope to see greater insights into reimbursement, technical development, and other facets of the dynamic digital therapeutics industry.”
Are you interested in learning more about Biorasi’s approach to project management for digital therapeutic clinical trials? Contact us today for our insights into this evolving market.