Pink Sheet

Digital Health Technologies: Use In Clinical Studies Comes With Practical Challenges

28 Apr 2023

Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.

Smartwatch — Patients generally prefer to wear their own smartwatch if one is needed for clinical trial participation. • Source: Shutterstock

Digital health technologies hold tremendous promise in drug development, including bringing clinical trials to patients and providing a more consistent, and less intrusive, assessment of function and disease impacts.

However, sponsors, investigators and regulators must weigh a host of practical considerations when deciding whether and how to build digital...