Making Sense of Sensors: Challenges in Developing Patient-Centered Sensor-Based Outcomes (eg Wearables) for Use in Medical Product Decision-Making and Challenges to Adoption in the Real World

PURPOSE:

Evaluating challenges in the development and use of SBOs for medical product decision-making and adoption in the real world by clinicians and payer initiatives is warranted. Considerations for addressing challenges will draw from case studies in developing patient-centered SBOs and barriers to adoption in clinical practice.

Learning objectives include:

1. Identifying the challenges and considerations in applying the Patient Focused Drug Development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product decision-making
2. Exploring strategies to improve SBO adoption

DESCRIPTION:

Sensor-based outcomes (SBOs) are collected using sensor technologies (e.g., wearables, bed mats monitoring sleep) and may be considered clinical outcome assessments (COAs). Challenges in development and adoption of patient-centered SBOs have hindered the promise of continuous data collection and monitoring in the real world to improve outcomes and reduce health care costs. While there are helpful frameworks for developing and adopting SBOs from multiple organizations (C-Path, DiMe, Transcelerate) and guidance from the FDA and EMA, these do not easily align to the COA development process or include detailed considerations for challenge areas, including identification of patient-centered concepts of interest that map to measures captured by SBOs (e.g., do improvements in ‘stride velocity’ relate to a patient’s ability to complete daily activities?), use of data-driven or AI-enabled approaches to identifying candidate SBOs, cognitive debriefing, and defining meaningful change. Challenges for adoption in real-world practice by clinicians and payers include the lack of incentive and technology costs. To address methodological and adoption challenges, COA and Digital Health experts will share considerations to address challenges using case studies (e.g., 95^th percentile of stride velocity, the first qualified SBO endpoint by the EMA; Aetna and United Healthcare initiatives). Attendees will take part in interactive polling about the case studies and share their thoughts on challenges and opportunities.