Digital Biomarkers Solution May Enable Smaller And Faster Clinical Trials

With the increasing number of therapies being developed for Huntington’s Disease, there is a growing need for sensitive measures of disease progression to facilitate Phase 1/2 trials with a recruitable size. Roche's HD digital biomarker solution has been employed across multiple studies, amassing a dataset of over 1,000 individuals with HD. From this data, Roche has developed a digital motor score and validated it using data from a fourth study.

Analysis has shown that the HD Digital Motor Score (HDDMS) possesses greater sensitivity than the composite Unified HD Rating Scale (cUHDRS) in ISS Stages 2 and 3. Moreover, using the digital motor score to power a study can result in a 75% reduction in sample size. This promising outcome highlights the potential for smaller and faster early-stage trials, which is particularly beneficial for a rare disease with a limited pool of participants.

Learn more about how sponsors of Huntington’s disease (HD) clinical trials can potentially obtain earlier indications of progress by utilizing digital biomarkers by downloading the brochure below.