USA – FDA updates clinical trial guidance for drugs, devices

The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and postmarketing requirements.

The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. (RELATED: FDA unveils guidance for trials impacted by COVID-19Regulatory Focus 18 March 2020; Clinical trials during COVID-19: Updates from FDA, MHRA and TGA, Regulatory Focus 1 April 2020; FDA, EU authorities update guidance on clinical trials during COVID-19Regulatory Focus 28 April 2020).
For protocol deviations and amendments to ongoing trials, FDA now says that deviations should be included in final study reports and can be included in annual reports. The agency also explains that for device studies conducted under an investigational device exemption, the requirements to get FDA approval before making changes to an investigational plan “do not apply to changes made to protect the life or physical well-being of a subject in an emergency, including study-wide changes, but such deviations must be working days.”
In another change from earlier versions of the guidance, FDA says it expects sponsors to perform a risk assessment when considering alternative arrangements for administering investigational products via infusion, such as at a patient’s home. FDA says the risk assessment should consider “the nature of the investigational product and the potential risk to both the trial participants and the health care providers responsible for administering the product at the alternative site.” Sponsors are then instructed to contact the appropriate review division at the agency to discuss their plans…