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.
You may also be interested in...
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.
Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.