Findings
Developing a novel endpoint requires an iterative and patient-centered approach, beginning with defining the study population and relevant health aspects.
Concepts of interest (COIs) must be specific, measurable, and clinically meaningful, with input from patients and caregivers.
Endpoint validation includes defining meaningful change, ensuring content validity, and demonstrating the ability to detect change.
Digital tools must meet criteria for usability, analytic validity, and tolerability within the target population.
Regulatory engagement and alignment throughout the process are critical to endpoint acceptance.

Recommendations
Define the study population and context of use (COU) early to guide endpoint and technology selection.
Identify meaningful health aspects (MHA) and concepts of interest (COI) with input from patients and clinicians.
Select and validate DHTs based on performance, usability, and their ability to capture meaningful data.
Establish meaningful change thresholds and validate endpoints in real-world settings.
Engage with regulators at every stage to align endpoints with evidentiary and regulatory standards.

Regulatory Considerations
Define and validate meaningful change thresholds that reflect treatment benefits for regulatory acceptance.
Ensure DHTs meet analytic validity standards, including accuracy, reliability, and reproducibility.
Demonstrate content validity, ensuring that endpoints accurately reflect the intended COI across the full range of anticipated data.
Align with regulatory requirements to incorporate validated endpoints into pivotal trials.
Address usability, data privacy, and compliance concerns to meet regulatory and operational standards.