Findings
Digital health technologies (DHTs) enable the creation of novel endpoints that can represent the patient experience more objectively and accurately than traditional measures.
Endpoints derived from DHTs may be more meaningful to patients, healthcare providers, and other stakeholders.
The CTTI pathway for developing novel endpoints is applicable across various chronic conditions, with specific case studies developed for Duchenne Muscular Dystrophy, Diabetes, Parkinson’s Disease, and Heart Failure.

Recommendations
A systematic approach should be used to identify and develop key novel endpoints from digital health technologies.
Development should focus on creating measures that are meaningful to patients.
Stakeholders—including patients, regulators, and investigative site personnel—should be engaged early and often in the planning process.
Biostatisticians and data scientists should be involved in key decisions regarding protocol design, data collection, and analysis.
Novel endpoints should be incorporated as exploratory endpoints in existing clinical trials and observational studies to gather evidence

Regulatory Considerations
Developers are advised to engage with regulators like the FDA early and frequently when planning the development of a novel endpoint.
There are established processes for interacting with the FDA, and resources are available to guide developers through these interactions.
The principles of adaptive trial design are the same for studies using mobile technologies as they are for traditional clinical trials.