On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic. The guidance was a jointly issued from CDER, CBER, and CDRH as well as the Office of Good Clinical Practice at FDA, and was issued as “final” for immediate implementation without the usual period for public comments, owing to the urgency of the current public health emergency. However, comments can still be submitted to FDA if desired.
FDA Guidance Key Points:
The Guidance Document outlines considerations for ongoing trials, where of course the safety of participants is paramount, and advises that keeping trial participants informed is critical. The Guidance addresses the responsibilities of Sponsors, IRB/IECs and Investigators to determine if continued participation and test article administration is warranted, and to address topics such as supply chain interruptions and the nature of the disease under study. Study participant visit schedules may be substituted by remote contact (phone, virtual visits, alternate locations, etc.) and similarly remote monitoring activities will have to be used if the alternative monitoring approach can still assure adequate monitoring.
COVID-19 screening, if mandated by local requirements, need not be a cause for protocol amendments unless the Sponsor is collecting data as part of a new research objective.
FDA Guidance limitations
The Guidance cannot provide specific advice for any particular trial, but notes that variances in general should have IRB/IEC approvals, and that Sponsors should consider implementing or revising policies and SOPs to accommodate trial functions during a disrupting event like the COVID-19 outbreak. FDA says, “Efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, will be important.” Sponsors should contact the relevant review division at FDA to obtain advice about specific trials.
FDA also issued some additional Guidance Documents about COVID-19 this week, which include the first one noted above:
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards
Contains Nonbinding Recommendations Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Public Health Emergency Guidance for Industry and Food and Drug Administration Staff
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry – fda.gov
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff