Are Digital Endpoints Fit for Health Technology Assessment?

ISSUE: More clinical trials and real-world evidence studies are using digital endpoints, which are outcomes collected using digital tools such as wearables. These endpoints can provide useful information on how patients are functioning between clinic visits and do not rely on patient recall or opinion. There is little experience with them, however, so lack of validation and uncertainty over patient compliance mean they are not commonly considered by HTA bodies. This panel will discuss whether there are any scenarios where digital endpoints are ready to be considered in HTA, what the pros and cons are of using digital endpoints, and what researchers and HTA bodies need to do to allow digital endpoints to be used for decision making in the future.

OVERVIEW: Each panellist will have 10 minutes to outline their case. This will be followed by a debate amongst panellists, moderated by Jeanette Kusel. The audience will have the opportunity to pose questions to the panellists and polls will be used to elicit audience opinion. Dr Jacoline Bouvy will explain why HTA bodies are excited about the prospect of digital endpoint, but currently cautious about their use to inform decisions. She will discuss what is needed in terms of validation and links to health-related quality of life for HTA bodies to be more reassured of their use. Prof Lynn Rochester will highlight recent efforts that support cases where digital endpoints have been developed, validated and can be used in decision-making, highlighting the case study of the Mobilise-D initiative. Dr Kai Langel will highlight the work that is ongoing through the DEEP initiative to make digital endpoints fit for purpose for decision making. This panel will be of interest to all those involved in technology development and evaluation.