Although the impact of COVID-19 on trials will vary based on many factors, the FDA outlined considerations to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize the risks to trial integrity.
The FDA issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the novel coronavirus (COVID-19) pandemic.
Although the impact of COVID-19 on trials will vary based on many factors, including the nature of disease being studied, the trial design, and in what regions the study is being conducted, the FDA outlined considerations to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize the risks to trial integrity.
“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA, said in a press release. “The 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.”
The considerations for ongoing trials include:
In general, if policies and procedures are not already in place for applicable trials, sponsors, clinical investigators, and IRBs should consider establishing and implanting policy and procedures that address the possible disruption to the study as a result of COVID-19.
For all trials that are impacted by the COVID-19 pandemic, the FDA recommends including in the clinical study report:
“Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate,” the authors of the guidance wrote. “This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.”
1. Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials [news release]. FDA. Published March 18, 2020. fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials?utm_campaign=031820_PR_Coronavirus%20Update%3A%20FDA%20Issues%20Clinical%20Trial%20Guidance&utm_medium=email&utm_source=Eloqua. Accessed March 18, 2020.
2. FDA. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. FDA website. Published March 18, 2020. fda.gov/media/136238/download. Accessed March 18, 2020.