With venture capital pouring in from investors eager to support digital therapeutics, the sky seems to be the limit for this burgeoning industry. There is certainly great promise for scalable, convenient, evidence-based digital solutions, but the success of the industry — as well as the improved mental health of the people it aims to help — very much depends upon products rooted in high quality research designed to meet the needs of the masses.
Hitting the sweet spot of good technology, good evidence and equal access is a concern for many in the industry, and Big Health’s Vice President of Clinical Development and Medical Affairs Dr. Jenna Carl recently moderated a panel discussion on the topic at the DTx West 2021 conference. Let’s highlight a few key takeaways.
Meeting the gold standard
Dr. Andrew Krystal, professor of psychiatry at University of California San Francisco, said it’s important for digital therapeutics companies to demand the gold standard of research — randomized placebo‐/sham‐controlled trials that ensure participants are randomly assigned to intervention and control groups. This is the “gold standard” because it gives researchers more confidence that improvements in measured outcomes are due to the intervention and not some other factor (e.g., participant bias, natural disease course, etc.). Because there currently is no research standard, many clinicians may be reluctant to incorporate digital therapeutics even though there is tremendous potential to improve the quality of care of their patients.
“Because there currently is no research standard, many clinicians may be reluctant to incorporate digital therapeutics even though there is tremendous potential to improve the quality of care of their patients”
You don’t know what you don’t know
Dr. Juliette McClendon, assistant professor of psychiatry at Boston University School of Medicine, talked about a historic problem with clinical trials: the underrepresentation of certain racial and minority groups that results in gaps in scientific evidence. While she says some researchers and institutions have made efforts to address the disparity, it’s a complex problem. Scientists should take steps to reach out to underserved populations, even if it means thinking about new ways to connect with and recruit underrepresented people. Once interventions are in the marketplace, she said it should also be noted that the same individuals underrepresented in trials may also lack consistent access to wifi, computers, smartphones, and other equipment necessary to benefit from digital therapeutics.
“Scientists should take steps to reach out to underserved populations, even if it means thinking about new ways to connect with and recruit underrepresented people”
It’s the wild, wild west
Anthem, Inc.’s Director of Clinical Analytics and Research Digital Care Delivery Dr. Jordan Silberman says the world of digital therapeutics is like the “wild west.” There’s a lot of opportunity out there, but he sees three types of companies trying to make their way: those (like Big Health) that demand evidence-based research to support their interventions, those that don’t do anything at all, and the most problematic group — those that profess to be highly committed to evidence but, upon close inspection, that evidence lacks rigor.
While it will take a few years for a consensus to develop, his hope is that evidence standards are agreed upon sooner than later. Otherwise, he says, the industry runs the risk of a massive adoption of digital solutions that have the best marketing, but not the best efficacy — a scenario that is bad both for patients and the industry.
“Otherwise, he says, the industry runs the risk of a massive adoption of digital solutions that have the best marketing, but not the best efficacy — a scenario that is bad both for patients and the industry”
The back story
Brian Dolan, founder of Exits and Outcomes says part of what contributes to the “wild west” style of operating is that digital therapeutics companies are venture backed and trying to get to market quickly. There’s a lot of money in the space, and the focus (for some) is on getting quick traction among potential customers who may or may not have sophisticated understanding of what it means for an intervention to be evidence based.
Dr. Carl summed up the panel’s overarching concern about just how bad a lack of evidence standards could be for digital therapeutics. “Patients may not know that high-quality care exists, so if they start off with a poor intervention they may think they can’t be helped.” While that’s terrible for the patient, Dr. Carl also says it is detrimental to the industry as a whole. “It’s hard to quantify the risk of slightly helpful care.”
“It is hard to quantify the risk of slightly helpful care”
To watch this fascinating conversation in its entirety, check out a recording of the full panel!
P.S. We also created a Guide to Clinical Evidence to help employers navigate the complexity of clinical evidence. Check it out!
Watch the presentation
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