In August 2021, the US FDA issued guidance for the Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency for Industry, Investigators, and Institutional Review Boards (IRBs).
This guidance issuance provides the general considerations to assist sponsors in assuring the safety of clinical trial participants, and for maintaining compliance with the good clinical practice (GCP) norms, while minimizing risks to the clinical trial integrity for the duration of the COVID-19 public health emergency. The scope of this guidance covers the critical information pertaining to the key areas including considerations for ongoing trials, general information and guidance regarding policies and procedures that are not already in place for the applicable trial, and scope of all trials impacted by the COVID-19 public health emergency.
Due to the unprecedented COVID-19 pandemic situation, the guidance explains that COVID-19 public health emergency may impact the conduct of clinical trials of medical products, and the FDA recognizes that the study protocol modifications may be required, including unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. Further empathizing that the efforts to minimize impacts on clinical trial integrity, and to document the reasons for protocol deviations, will be critical. This guidance also includes various topics pertaining to the conduct of clinical trials, investigational new drug (IND) and investigational device exemption (IDE) protocol changes, safety reporting, and related post-market compliance topics within the section of questions and answers located in the appendix section. Therefore, this guidance provides a helpful reference to the industry, Investigators and IRBs for the conduct of ongoing and prospective clinical trials during the COVID-19 public health emergency.
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