US FDA Oncology Center Wants Trial Datasets Flagged As Remote Or In-Person Assessments
Agency wants to use pandemic-interrupted clinical trials to gauge how decentralized approaches impacted study integrity and to inform prospective use of such designs post-COVID.
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In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.
US FDA staffing problems and patient engagement enhancements will be listed as priorities during reauthorization kick-off meeting.
Oncology Center of Excellence’s Paul Kluetz says agency intends to explore the effects of decentralization, remote assessments and other approaches adopted mid-stream on safety evaluations, missing data and endpoint variability.