San Francisco, CA — Syneos Health Commercial Solutions Chief Strategy Officer Baba Shetty led a panel at the 2019 Digital Medicine & MedTech Showcase on the frontiers of digital therapeutics, featuring five of the foremost experts in this fast-emerging realm. Digital therapeutics, or DTx, are distinct from digital health products, and are driven by software programs that can be prescribed to prevent, manage, or treat a medical disorder or disease, as stated by the Digital Therapeutics Alliance. Panelists are closely involved in the development of these new medications, so Shetty asked them to address a matter on the minds of many people in healthcare: how do you do a clinical trial for software?
Yuri Maricich, Chief Medical Officer and Head of Clinical Development at Pear Therapeutics, which has recently partnered with Novartis, explained that DTx must go through trials that demonstrate not only a product’s efficacy but also—because the very concept is so new—how to use it. “We have to run robust studies that produce evidence that allows clinicians and other key stakeholders to know how to use the product relative to other therapeutics,” he said. “These need to be studies of the caliber and rigor that any clinicians going to their professional medical society would expect.”
But some fundamental components of a clinical trial don’t translate in any obvious way to a scenario where it is software—rather than a traditionally administered therapy—being tested. For example: how do you make a software version of a placebo? Vincent Hennemand, Vice President of Strategy at Akili Interactive, shed light on how his team creatively surmounted these questions when developing their digital therapeutic for ADHD. “When your treatment looks like a video game, you ask yourself what kind of placebo can we use,” Hennemand said. “If it’s a randomized, double blind, you have to show something that is also a video game. We couldn’t find a product on the market that would fill the role of placebo, so we developed our own: it’s an educational word game like Boggle. It’s a video game with a cube with letters; you “shake” it, and there’s a random distribution of letters, and you have to invent words.”
Akili’s trial yielded positive results, and the company’s DTx is currently under FDA review. “We have an extremely positive relationship with the FDA,” said Hennemand. “They’ve been tremendously helpful regarding the emergence of this new industry. They worked with us and gave us insights into the guidelines that were not actually even issued yet.”
Susan Cantrell, C.E.O. of the Academy of Managed Care Pharmacy, emphasized that DTx developers will find real world evidence (RWE) to be particularly powerful when it comes to payer approvals. Though payers can often be seen as an impediment to marketplace uptake, Cantrell goes as far as to suggest that, presented with compelling RWE, payers “can be a partner to the companies as the products come to market, in terms of data collection and strategy for commercialization.” And that is one of the true value drivers of DTx, their ability to continuously capture data in a timely manner that can be used to measure outcomes in a real world setting, using those insights to demonstrate their impact and evolve their products to better care for patients. [You can read more about what Cantrell has to say on the topic in her own LinkedIn post, “Applications for Value: The Digital Therapeutics Revolution.”]
The development of DTx introduces a number of discrete challenges and opportunities, especially with regard to collecting robust evidence that supports the outlined value proposition. Early and proactive dialogue with regulators is key, validating proposed clinical development programs, from the design of an appropriate digital placebo that behaves in a similar way without clinical intent, to how you designate your control arm vs. standard-of-care. Regulators are interested and want to support this nascent sector. But it’s not all about regulatory approval; co-developing with users and focusing on the experience is also key. Simple things, such as how to optimally wear a biometric patch, can be controlled for in a clinical trial but not in the real world. User-centric design that creates value for the end-user will support real-world utility, which in turn increases the quality of the data collected, and provides the continuous metrics that demonstrate the impact the DTx intervention delivers.
Read more of our perspectives about digital therapeutics: what they look like and what’s needed to make them available to the public by clicking here. You can read an executive summary of our upcoming report here.