The utility and impact of digital endpoints for improving breast cancer outcomes

Introduction: In breast cancer clinical trials utilizing digital endpoints, wearable sensors record participants’ health information during activities of daily living.  These sensors are worn on the wrist or finger, placed as a skin patch or headband, or embedded on clothing. Data collected from wearable sensors form the basis of a digital endpoint, useful for determining effects of novel treatments on health outcomes, particularly quality-of-life outcomes. Areas covered: References for this article were selected from a PubMed search spanning from 1 January 2017,to 1 July 2024, using the terms ‘wearable sensors,’ ‘digital endpoints,’ ‘virtualtrials,’ ‘breast cancer.’  Additional articles from the authors’ personal collection of papers and reviewers suggestions were also used. Expert opinion: Digital endpoints must be validated as proper surrogate measures for healthcare outcomes, prior to their use in breast cancer trials.  Wearable sensors may introduce biases, such as ‘missing not-at-random bias,’ and perhaps even exacerbate disparities in healthcare outcomes if patients not comfortable with their use are excluded from clinical trials, or if the accuracy of sensors varies between racial and ethnic groups. Therefore, before embarking on trials with digital endpoints, validation studies are required, and limitations and risks of such trials need to be addressed.