Digital measures in Clinical Trials: Development & Validation assessment

 Digital measures (both digital-enabled measures and novel digital biomarkers) have the potential to form part of clinical development programs, but there are still a lot of questions to be addressed before this becomes a reality. In this meeting we will focus on: 

-What does the development process look like (both for software/algorithms and hardware)? What is the role of third parties like Apple?
 -Who are the stakeholders involved in the development process (e.g clinicians, patients, engineers, etc)?
-Technical and clinical validation of digital measures: who is responsible for this validation, requirements of the different stakeholders, validation of software vs. hardware and how to deal with software updates/iterations.
- Standardization of understanding/interpretation across the field: what is the role of initiatives like the DATAcc, EVIDENCE and the V3 Framework from DiMe or the Digital Biomarker Discovery Pipeline?