Cancer Trials: Patient-Reported Outcomes Should Measure Five Core Concepts, US FDA Says
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in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.
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Patient-Reported Outcomes: Open-Label Trials Can Be Designed To Minimize Bias, US FDA Says
With the expectation for increasing amounts of patient experience data comes the need for the FDA and sponsors to consider, and account for, the degree to which open-label bias influences oncology trial PROs; agency staff suggest trial design elements and analytic approaches for dealing with bias at a meeting on cancer clinical outcomes assessments.
Ready, Set, Go: China To Use Patient-Reported Outcomes In Clinical Studies
As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.
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.