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The growing number of clinical trials the kidney community has enjoyed over the past few years is endangered due to the COVID-19 pandemic. Concerns over the safety of trial participants and investigators are paramount and are leading to rapid changes in the conduct of clinical trials.
The US Food and Drug Administration (FDA) released “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, updated March 27, to provide clarity to the clinical trial community. Considering this guidance and after soliciting reactions from the clinical trial community, the Clinical Trials Transformation Initiative (CTTI) hosted a webinar on March 31 titled “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID”.