📢 This week, our paper entitled ”Impacts on study design when implementing digital measures in Parkinson's disease-modifying therapy trials” was published online in Frontiers in Digital Health.
In this publication we explore the effect that digital health technologies can have on clinical trial study design. We show that compared with quarterly in-clinic assessments, frequent at-home measures for example can reduce the sample size needed to detect a 30% reduction in disease progression from over 300 per study arm to 100 for evenly spaced at-home assessments.
Specifically, we get to these results by estimating the test-retest reliability of a suite of at-home motor measures performed using a smartphone device. The estimates are used to simulate digital measures in disease modifying therapy clinical trials. We considered three schedules of assessments and fit linear mixed models to the simulated data to determine whether a treatment effect can be detected.
Our results indicate that different derived at-home measures have varying reliability; many have ICCs as high as or higher than MDS-UPDRS part III total score.
The results regarding superiority of at-home assessments for detecting change over time are robust to relaxing assumptions regarding the responsiveness to disease progression and variability in progression rates.
Read our paper here 👉 https://lnkd.in/e3vPTcRA
#digitalhealth #Parkinsons #clinicaltrials
Co-Founder and CEO at PanAgora Pharma
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