Cancer Trials: Beware Of ‘Digital Exhaust’ When Planning Clinical Outcome Assessments
Patient data gathered through wearables and sensors can complement traditional patient-reported outcome assessments, but continuous digital monitoring runs the risk of overburdening clinical trial participants.
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US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.
Heterogeneity in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.
Clinical Trial Diversity Planning Requires Prevalence-Based Enrollment Goals, Metrics For Gauging Success
Academic and industry experts caution against relying on historical enrollment numbers when setting new targets for under-represented populations and tout real-time monitoring dashboards, as well as a role for data monitoring committees, in assessing whether targets are being met in ongoing studies.