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The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.
On March 18, 2020, FDA released a guidance for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
In a press release outlining the details of the guidance, FDA acknowledged the impact potential quarantines, site closures, travel limitations, and interruptions to the supply chain will have on the conduct of clinical trials of medical products, including drugs, devices, and biological products. The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity. The considerations include sponsors evaluating alternative methods for assessments and offering further safety monitoring for trial participants who no longer have access to investigational products or the investigational sites.
“With this guidance issued today, FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” said Anand Shah, MD, FDA deputy commissioner for Medical and Scientific Affairs, in the press release. “[FDA] released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”