I read this study recently. The conclusion was that the Medisafe app slightly helped with medication adherence for anti-hypertension medications but didn’t actually reduce blood pressure compared to the control.
The study design caught my eye. The study, which was conducted by Evidation Health, was entirely remote, using a Bluetooth blood pressure monitor and the Medisafe app. The fully remote nature seemed to actually yield a more diverse participant pool than I normally see. For example, 25% of participants were black — a population disproportionately affected by high blood pressure, but that also has much lower clinical trial participation (~7%).
The nature of virtual trials means recruitment can happen across a much more diverse demographic pool, in no small part because you don’t have to force people to travel to a site or choose high population density areas that might have enough participants. We predicted that 2018 would be a year we’d see more virtual trials for these reasons, plus the fact that they’re potentially much cheaper to run.
The efficacy gap
The study also made me wonder about digital therapeutics and randomized control trials (RCT) as a whole. There’s the concept of the “efficacy-effectiveness gap,” which highlights the fact that randomized trials don’t necessarily reflect what the real world is like, and therefore many drugs perform differently when they’re actually in clinics. This is one of the reasons using real-world data to accelerate drug approvals is getting popular — it can help use close this gap.
But what if the “efficacy-effectiveness” gap actually has the opposite problem for digital therapeutics, where the app has iterated, gotten more data/feedback, and is now better in the real world than the trial? Software constantly updates and improves — think about how quickly all of your other apps update.
Should we be confined to a single-point analysis to assess whether a software-based intervention is effective? There’s probably an alternative which combines real-world usage with the gold-standard RCT that can give us a better understanding of how well these digital therapeutics work. That’s why keeping an eye on the FDA’s pre-certification program is important to see what it’s going to care about (which already emphasizes real-world data).
Digital therapeutics are a natural fit for virtual trials since the therapy itself is remote. The space is getting more and more attention every day, spearheaded by FDA-approvals like Pear Therapeutics as well as pharma + insurers who have become increasingly interested.
We put together a list of 22 different digital therapeutics companies that are looking to take advantage of this interest in using software to achieve health outcomes for our expert intelligence clients. Check them out.
As the space continues to take off, there are other ways to capitalize besides just the therapeutics themselves. There are picks & shovels opportunities behind this wave. One example is Evidation Health, mentioned above, which aims to design and power the studies for these solutions. Xealth wants to be the place doctors can actually prescribe these digital solutions and monitor patients. I’m sure in the future there will be a service that helps to accredit virtual coaches too (e.g. diabetes coaches).
Any other picks and shovels plays you can think of?