12 Jul 2022
The Debrief
Every week, HealthXL communities connect to tackle the challenges in digital health. If you missed any of these meetings, here are some key takeaways from the past couple of weeks.
DTx in Mental Health: Building Clinical and Economic Evidence
There is clear tension between gathering excellent clinical evidence and building a solution with the best user experience that satisfies the patient. This tension stems from whose needs a DTx company wishes to meet, regulators and partners who value evidence or end users who value user experience. A balance needs to be found between them to satisfy all parties.
Masterclass: Clinical Trials Design for Digital Health Products
As a framework to consider for study design, we describe the following
- Descriptive trials (cross-sectional surveys and qualitative case reports/series) as a means for hypothesis generation although they do have small sample sizes.
- Analytic trials that are experimental randomized for hypothesis testing.
- Observational analytic trials for the generation of RWE
What Label Claims Can You Make About Your DTx?
Label claims cannot be universal for one solution due to regulation differences across regions. A digital solution could be regulated as a prescription DTx (PDT) in one region, but a non-prescription DTx in another region. Regulations control what label claims we can make about DTx solutions. So, these products, that are not equivalently regulated across regions, may not have the same label claims everywhere. This makes it hard for DTx companies to standardize commercialization strategies across countries, which could affect scalability.
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