FDA Guidance for Clinical Trials During COVID-19 Pandemic

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:

• Sponsors should consider each circumstance, assess the potential impact on the safety of trial, and modify study conduct accordingly. Decisions regarding this could include continuing trial recruitment, continuing use of the investigational product for patients already involved in the trial, and the need to change patient monitoring throughout the trial. Regardless, in all cases, it is crucial that participants are kept informed of any changes that could affect them.

• Sponsors, in consultation with clinical investigators and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), may decide that the protection of a subject’s safety, welfare, and rights would be best served by continuing or by discontinuing use of the investigational product or participation in the trial. However, such decisions will depend on the specific circumstances.

• Given that trial participants may be unable to come to investigational sites due to protocol-specified visits, sponsors should assess whether alternative methods for safety evaluations could be implemented when necessary and feasible. Additionally, in deciding to continue or discontinue use or administration of the investigational product, sponsors should consider whether the safety of participants can be ensured by implementing the alternative approach.

• In some cases, trial participants may require additional safety monitoring.

• COVID-19 screening procedures that may be mandated by the health care system in which a clinical trial is being conducted do not need to be reported within the trial protocol unless the sponsor is incorporating the data as part of a new research objective.

• Due to possible changes in study visit schedules, missing visits, or patient discontinuations, it will be imperative to capture specific information in the case report that details the basis of missing data, including the relationship to COVID-19.

• In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented; however, if scheduled visits will be significantly impacted, alternative secure delivery methods may be explored.

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:

• Contingency measures implemented to manage study conduct during the disruption.

• A listing of all participants affected by the COVID-19 related study disruption by unique number identifier and by investigational site, with a description of how the subject’s participation was altered.

• Analyses and corresponding discussions that address the impact of implemented contingency measures on the safety and efficacy results reported.

“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.”

References:

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.