Digital technologies: Innovations that transform the face of drug development

Area of Science:

• Digital Health Technologies
• Clinical Trial Innovation
• Biomarker Development

Background:

• Digital health technologies (DHTs) and digital biomarkers are increasingly used in clinical research.
• Implementation of DHTs in clinical trials presents operational, ethical, and regulatory challenges.

Purpose of the Study:

• To discuss the challenges and perspectives of integrating DHTs in clinical trials from industry, regulatory, and public-private partnership viewpoints.
• To highlight complexities in DHT implementation, including regulatory definitions, validation scope, and inter-sector partnerships.

Main Methods:

• Gathering diverse stakeholder perspectives (industry, US regulators, public-private consortium).
• Analyzing challenges related to translating DHT measures into clinically meaningful endpoints.
• Examining the Wearable Assessments in the Clinic and Home in PD (WATCH-PD) study as a case example.

Main Results:

• DHT implementation involves complexities in regulatory definitions, validation, and BioPharma-tech sector partnerships.
• Key challenges include translating DHT measures, ensuring participant safety, training, retention, and data privacy.
• The WATCH-PD study demonstrated benefits of pre-competitive collaboration, including early regulatory feedback and data sharing.

Conclusions:

• Advancements in DHTs will drive device-agnostic measures and patient-reported outcomes in drug development.
• Further efforts are needed to define validation experiments, incentivize data sharing, and establish data standards.
• Multistakeholder collaborations through pre-competitive consortia are crucial for widespread acceptance of DHT-enabled measures.