Today, less than 15% of clinical trials capture data from mobile sensors. In many cases these data are used to derive exploratory endpoints, but in some cases they are being used for primary or secondary endpoints.
Mobile sensors collect data that can measure aspects of health and function which are difficult to assess by other means and they enable more frequent assessment outside of the clinic environment. In clinical research, they have the potential to provide deeper insight into intervention effects. However, uncertainty remains in how to select a device that is acceptable to regulators and patients, how to implement mobile sensors appropriately within study protocols, and how to interpret the data they provide.
In this webinar, our experts will discuss these topics with particular reference to activity and sleep monitoring. They will explore current thinking on evidentiary requirements to support mobile sensor selection and clinical endpoint development, as well as approaches to operationalizing the use of mobile sensors that account for the site staff and patient experience.
Topic of discussion:
● Criteria for selecting mobile sensors suitable for clinical trials
● Considerations for deriving validated endpoints that support labeling claims
● Approaches to implementation of mobile sensors in clinical trials