Findings
DHT selection should be guided by the trial’s scientific goals, unmet needs, and potential to reduce participant burden.
Verification ensures the DHT accurately measures physical parameters, while validation confirms it reliably captures the desired clinical outcomes.
Conducting feasibility studies is essential to identify potential usability or compliance issues before full trial implementation.
Clear communication, training, and support plans for participants and sites are critical to the success of DHT-enabled trials.
Operational challenges, including DHT malfunctions, must be anticipated with robust management and mitigation plans.

Recommendations
Define Measurement Goals: Identify the scientific and patient-centered needs driving the decision to use DHTs.
Specification-Driven Selection: Tailor DHT selection based on technical performance, trial needs, and participant preferences, collaborating with manufacturers for transparency.
Verify and Validate Technologies: Conduct both verification and validation processes in controlled and real-world settings, focusing on the target population.
Pilot Feasibility Studies: Test the DHT in small-scale studies to assess usability, compliance, and real-world functionality.
Operational Planning: Develop detailed standard operating procedures (SOPs) for managing DHTs, addressing potential malfunctions, and supporting participants.

Regulatory Considerations
Regulatory status should not solely determine DHT selection; instead, focus on its fit-for-purpose performance in the trial context.
Maintain transparency with manufacturers to document DHT performance characteristics and limitations for regulatory submissions.
Validate endpoints and DHT data to meet evidentiary standards required by regulatory agencies.
Ensure clear roles and responsibilities for managing DHTs to align with regulatory compliance requirements.
Address interoperability, data privacy, and security concerns to adhere to ethical and legal standards in clinical trials.