Findings
There is a need for a structured framework to leverage prior work in the use of DHTs in clinical trials.
The current body of evidence supporting DHTs is growing, but there is a lack of clarity on how to effectively utilize this evidence.
The V3 framework provides a process for validating DHTs, but its application across different medical product development programs is inconsistent.

Recommendations
Implement a framework to reuse analytical and clinical validation data for existing DHTs.
Encourage early and continuous communication with regulatory health authorities.
Leverage prior work to share best practices and consistent approaches in employing DHTs.
Use the V3 framework to ensure DHTs are fit-for-purpose in clinical trials.
Develop a strategic approach to incorporate DHTs and digitally derived endpoints within clinical development programs.

Regulatory Considerations
Sponsors should ensure their plans to leverage prior work are endorsed by regulatory health authorities.
Alignment with FDA guidance on digital health technologies is crucial.
The regulatory status of the DHT and its intended use should be clearly defined and considered in clinical trial applications.