FDA Guidelines for Conducting Clinical Trials During COVID-19 Pandemic

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The Food and Drug Administration (FDA) of the United States of America has recently issued a statement, updating Research Sites, Investigators, and IRBs on how best to deal with the ongoing challenges posed by COVID-19. These guidelines will help ensure the safety of trial participants, compliance with good clinical practice (GCP), and minimizing risks to trial integrity.

To quote directly from the release, “[the] FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. FDA recognizes that protocol modifications may be required and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures.”The release includes detailed and specific measures sites can take to ensure the safety and integrity of the study is not affected by this global crisis. To read the full FDA release, click here.