FDA, NIH Issue Guidance on Conducting Clinical Trials During a Pandemic

The FDA recently issued several guidance documents that provide recommendations on how to conduct clinical trials during the COVID-19 pandemic. The Agency recognizes that the pandemic may require protocol modifications to clinical trials and offers guidance to sponsors, clinical investigators, and institutional review boards regarding ongoing trials, as well as trials that do not yet have policies and procedures in place.

The FDA outlines reporting requirements for contingency measures, expectations for postmarketing adverse event reporting, and policies for risk evaluation and mitigation strategies (REMS) requirements when patients self-isolate or are subject to quarantine. In addition, the Agency indicates how to leverage current non-invasive patient monitoring technology to help eliminate unnecessary patient contact and ease burdens on hospitals and other health care facilities at this time. Questions related to gene and cell therapy trials may be submitted to the Center for Biologic Evaluation and Research.

The National Institutes of Health (NIH) has provided a series of guidance documents about the flexibilities they are allowing for NIH-funded research and clinical trials in light of the COVID-19 pandemic. The guidance covers issues such as proposal submission and award management, human subjects and clinical trials, animal welfare, and peer review. Though guidance documents for each subject should be consulted directly, the overarching theme is that NIH is concerned foremost for human health, and will therefore be administratively flexible if research and trials are impacted. NIH is collecting all relevant guidance, as well as other resources for researchers, on a central webpage.

Among the resources for clinicians who administer gene and cell therapies and their patients, the American Society for Transplantation and Cellular Therapy (ASTCT) has developed a resource community. The FDA also has compiled questions and answers for patients about clinical trials during the COVID-19 outbreak. If you have additional questions about gene and cell therapy research and treatment during the COVID-19 pandemic, please contact ASGCT.

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