Standalone DTx: Clinical & Economic evidence

As Standalone DTx are trying to find their place in the healthcare industry, they are asked for high-standard clinical and economic evidence, just like the big player in the market: drugs. However, drugs and standalone DTx are completely different in nature and building evidence that is meaningful for the different stakeholders is an arduous task for DTx companies. Join this peer-to-peer conversation to discuss the following:

- Clinical & Economic evidence requirements for standalone DTx - how does this change depending on the stakeholder, risk of the product, disease, geography, etc?  

- How do you align the evidence generation strategy with the commercial strategy from the beginning?  

- Particularities of the Study Design for standalone DTx (e.g comparators - standard of care vs. sham apps, inclusion/exclusion criteria, the role of RWE, BYOD vs. providing the device, etc)  

- How can the different stakeholders work together towards a standardized framework?