The Debrief

Positive results of digital health studies may be a critical componant of commercial success, but they do not necessarily always lead to it. Evidence generation and commercial strategies need to go hand in hand. They can be parallel, such as a soft commercial launch to improve the product while generating evidence in the meantime.

There is a big difference between pharma products and digital health. For digital health you never have a final product, the intervention matures over time. The evidence generation strategy for digital health should be reflect this difference. 

It is critical that there is efficient internal communication in the pharma company from the beginning of the study design. A lot of departments will need to get involved (medical, clinical operations, finance, regulatory, compliance, etc.), so onboarding all of them from the early stages is important, despite being a challenge for many companies. 

When incorporating digital measures to clinical trials, for pharma it is vital to engage regulatory bodies early on to make sure they select the right digital measures for the clinical trial. 

The evidence requirements change depending on the route to market you want to pursue. For example, pharma requirements are not the same as payers. It is critical to know this up front to build the right evidence generation strategy. 

Tracking safety in the long-term makes a lot of sense for drugs but for most DTx products, proving long-term efficacy becomes more important. Even when the product changes to cover new indications, it may not be necessary to focus on safety if it has already been shown for other indications. Safety evidence requirements should be specific to the product and/or disease.