With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic. Ensuring the safety of participants in ongoing trials is paramount, the agency said, urging investigators to consider phone contact and virtual visits as avenues to implementing altered monitoring.
The agency also called on sponsors and clinical investigators to engage with institutional review boards or independent ethics committees as early as possible when urgent or emergent changes to trial protocol or informed consent are anticipated as a result of COVID-19. When necessary to minimize or eliminate hazards or to protect research participants from circumstances that might expose them to COVID-19, changes may even be implemented without IRB approval or before filing an amendment to the trial's IND or IDE, so long as they're reported afterward, the agency said.
Emphasizing, as it often does, the need for documentation, the agency also urged study sponsors to thoroughly document changes in processes, patient participation, and study conduct throughout clinical study reports. Staffers also urged sponsors to ensure they address in the statistical analysis plan how protocol deviations related to COVID-19 will be handled for the prespecified analyses.
The "FDA recognizes that protocol modifications may be required, including unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures," the agency said. "Efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, will be important."
A handful of biopharma firms already have disclosed delays or disruptions to clinical programs, and it is anticipated many more such announcements will follow. See BioWorld’s list of COVID-19-related impacts on clinical trials.