Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says
Quarantines, travel restrictions and supply chain interruptions are likely to cause "unavoidable protocol deviations" in ongoing clinical trials, the 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 COVID-19.
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FDA: COVID-19 Vaccine Recipients Shouldn’t Be Shut Out of Clinical Trials
Clinical trials often exclude patients who are receiving other investigational treatments. But treatments such as vaccines that have been authorized via emergency use authorizations don’t count as “investigational,” the agency says.
Informed Consent: For COVID-Affected Studies, A Handwritten Document May Suffice
Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol, and texting or emailing a photo of the signed document to the investigator, the US FDA says in its latest guidance update.
For COVID-Impacted Studies, FDA Loosens Video Conferencing Rules
Use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, the US agency's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.