Appendix A
Workshop Statement of Task
Digital health technologies (e.g., smartphone apps, wearable sensors, and other remote, sensor-based tools that combine hardware and software) have become increasingly available to consumers, providers, and researchers. They offer new opportunities to address critical challenges or pain points, better connect patients and health care providers, and incorporate patient input throughout the drug research and development (R&D) lifecycle. This workshop will provide a venue to discuss challenges and opportunities in using digital health technologies to improve the probability of success in drug development. Workshop participants may consider key components for an evidence-based framework for applying digital health technologies toward drug R&D.
WORKSHOP OBJECTIVES
- Highlight critical barriers or pain points along the drug R&D lifecycle for which digital health technologies may be uniquely suited to address
- Consider lessons learned from currently validated digital health technology applications that could be generalizable for newer digital health technologies
- Consider opportunities to enable the practical application of digital health technologies for improving drug development (e.g., sharing best practices for the validation and use of digital health technologies, harmonizing guidelines across sectors)
- Consider strategies for evaluating and selecting digital health technologies that are fit-for-purpose in drug development (e.g., examining existing frameworks, establishing appropriate evidentiary criteria)
- Discuss privacy, ethical, and regulatory issues related to the use of digital health technologies