can be used in clinical trials to evaluate novel end points that provide information that was previously difficult or impossible to obtain. These technologies could also make trials more efficient… Click to show full abstract
can be used in clinical trials to evaluate novel end points that provide information that was previously difficult or impossible to obtain. These technologies could also make trials more efficient and less burdensome to participants while providing a more meaningful and complete understanding of patients’ conditions and responses. However, despite these potential benefits, of the >73,000 active clinical trials listed on ClinicalTrials.gov, only 55 digital efficacy end points are currently being used in industrysponsored trials of new medical products. Here, we highlight key points from a February 2020 workshop on remote digital monitoring convened by the Foundation for the National Institutes of Health Biomarkers Consortium, which involved experts from regulatory agencies, government, pharma and biotech companies, technology developers, patient groups and a variety of consortia (see Related links for slides and recordings). We focus on points that could be immediately useful during the COVID-19 pandemic in situations where clinic visits are restricted by quarantine measures and travel restrictions and the eligibility and ability of patients to participate in trials is affected.
               
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