FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency
On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and answers to the guidance’s appendix. To learn more about the FDA’s guidance, please see our prior alerts here and here.
The guidance’s latest questions and answers tackle the following issues:
- Obtaining informed consent remotely, when electronic consent in not an option, including through the use of fax, email, and telephone. FDA’s prior guidance addressed obtaining informed consent for participants in COVID-19 isolation.
- Determining whether to implement remote performance outcome (PerfO) assessments and/or interview-based clinician-reported outcome (ClinRO) assessments, including considerations for minimizing variability, ensuring accuracy and reliability, ensuring feasibility for subjects with disabilities, protecting subject safety and privacy, and providing technical support to facilitate assessments.
- Conducting site monitoring visits, including source document review, remotely, including considerations for prioritizing sites for remote monitoring as well as remote document access options such as establishing a secure remote viewing portal, obtaining remote access to electronic health records, or uploading certified copies of source records to a sponsor-controlled electronic system or other cloud-based repository that contains appropriate security controls.
- Obtaining a short-term waiver from electronic common technical document (eCTD) requirements.
- Shipping investigational products to locations other than clinical trial sites (for example, local health care providers who are not sub-investigators), including appropriate documentation and required approvals. This topic was addressed more generally in FDA’s prior guidance.
- Local sourcing by clinical trial subjects or health care providers of investigational products that are FDA-approved for other uses, including compliance with investigational new drug (IND) regulations regarding charging for an investigational drug and labeling.
- Consulting with FDA review divisions on COVID-19 issues for drug and device clinical trials.
This updated guidance shows FDA’s efforts to respond in a timely manner to operational and logistical issues faced by researchers, institutional review boards, and clinical trial sponsors navigating these unprecedented times. We expect FDA will continue to update its question-and-answer appendix as it continues to engage with the research community on these topics.
As noted in our separate alert on the U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) guidance from April 8, 2020, OHRP has endorsed FDA’s guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” as consistent with the requirements of the Common Rule (the regulations applicable to research conducted, supported, or otherwise subject to regulation by 20 federal agencies, including the U.S. Department of Health and Human Services). However, it is unclear how questions and answers added to the appendix of FDA’s guidance after the issuance of OHRP’s endorsement will be treated.