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How do you run a clinical trial in the middle of a pandemic?

This week, FDA released guidance for sponsors conducting clinical trials on how to manage ongoing and planned activities. This guidance emphasizes patient safety and communication.   FDA noted that the decisions about continuing with patient recruitment and treatment, implementing alternative options for patient monitoring or visits, or discontinuing a trial may depend on specific, individual circumstances. Changes or missing information with regard to COVID-19 should be well documented, and the clinical study report should describe contingency measures, a list of all participants affected, and the analyses and corresponding discussions that address the impact.

The complete guidance document can be found here.