Client Alert: FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic
On March 18, 2020, the Food and Drug Administration (FDA) issued guidance for industry, investigators and institutional review boards (IRBs) related to the conduct of clinical trials during the COVID-19 pandemic.
This guidance (available here) recognizes that significant changes may need to be made to ongoing clinical trials in order to protect researchers and research subjects from COVID-19, and provides guidance and considerations to the industry to protect the safety of trial participants, maintaining compliance with Good Clinical Practice (GCP) and minimizing risks to trial integrity.
Huron Insights: This guidance provides sponsors, investigators and IRBs with direction in managing the conduct of ongoing clinical trials. Importantly, this guidance directs organizations to establish and implement policies and procedures to “describe approaches to be used to protect trial participants and manage study conduct during possible disruption of the study as a result of COVID-19 control measures at study sites.”
The Huron team of experts is currently working to develop policies, procedures and institutional considerations that organizations can use during this challenging time.
UPDATE: On March 27, 2020, the FDA updated this guidance to include an appendix with questions and answers related to the guidance. Huron’s experts have been working to develop resources and tools to manage research during this pandemic. Initial documents that we’ve developed are available here.