For COVID-Impacted Studies, US FDA Loosens Video Conferencing But Tightens Home Infusion Guidance
Also, use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, FDA's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.
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Clinical Trials: Industry Navigating Alternative Ways Of Delivering Investigational Drugs During Pandemic
New approaches include delivering study drug from a clinical site directly to a patient’s house through a courier service, as well as use of drones and automated dispensing units; future trials could see a mix of delivery approaches.
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.
Patient-Reported Data In COVID-Impacted Trials: US FDA Cautions Against Missing Data, Potential Bias
Considerations for switching from in-person to remote collection of patient- and observer-reported outcomes addressed in latest update to Q&A guidance, which also discusses Part 11 compliance requirements in the context of the pandemic and electronic collection of informed consent through MyStudies app.