A04 - Finding the Right Balance: Appropriate Secondary Use of Clinical Trial Data

Responses to questions not answered during the live session are included as a handout below.

Society has been hearing about the power and potential of health data for years. With improvements in computing power, cloud-based sharing, and increasing demands for large volumes of data to feed artificial intelligence and machine learning models, sponsors of clinical trials are seeing increased requests for broad, unlimited use of data from those trials. Using case studies, this session will describe examples of some of the proposed uses that can blur the line between what might be considered appropriate secondary use and what might run afoul of a participant's expectation based on their understanding of language in informed consent documents. These examples will highlight points to consider as HRP professionals reviewing protocols and participant-facing materials.