FDA’s clinical trial guidance stresses patient safety, studies’ integrity amid outbreak

As disruptions begin to mount among biopharmas’ planned or ongoing clinical trials during the COVID-19 outbreak, newly issued FDA guidance clarified the agency’s thinking on how sponsors can ensure participants’ safety and implement modifications to clinical trials while minimizing risks to the studies’ integrity.

In the document, issued Wednesday, FDA acknowledged that studies can be affected in many ways: by quarantines, site closures, travel limitations, supply chain interruptions, or infections of study site personnel or trial subjects. Any of those, or a combination of factors, can make it harder to meet study protocols and lead to deviations...