RARE Daily

FDA Issues Guidance on Conducting Clinical Trials During COVID-19 Pandemic

March 19, 2020

Rare Daily Staff

The U.S. Food and Drug Administration is encouraging clinical trial sponsors, clinical investigators, and institutional review boards put into place policies and procedures to be used to protect trial participants and manage studies during possible disruptions as a result of COVID-19 pandemic.

As a result of the pandemic, clinical trials are facing the potential disruptions from quarantines, site closures, travel limitations, interruptions to the supply chain for experimental therapies, and the risk of trial site staff or trial subjects becoming infected with COVID-19.

In response to that, the agency issued guidance for drug developers conducting clinical trials during the COVID-19 Pandemic in an effort to minimize risk to trial participants and need to maintain integrity of trials.

“These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures,” the agency said.

The guidance follows the U.S. Department of Health and Human Services’ declaration of a public health emergency related to COVID-19 and President Trump’s declaration of a national emergency in response to COVID-19.

Because of the public health emergency, the FDA said it was immediately implementing the guidance without prior public comment, but that it would remain subject to comment. The guidance is not legally enforceable but is meant to reflect the FDA’s current thinking and is intended to serve as recommendations.

The need for control measures and the impact of COVID-19 on individual trials will vary depending on the nature of disease under study, the trial design, where the study is being conducted, and other factors.  The agency outlined general considerations for sponsors.

It said sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify study conduct accordingly. Consideration may include whether to continue enrollment in a trial, use of an investigational product for patients already participating in a trial, and changes in patient monitoring during a trial.

Because trial participates may be unable to travel to trial sites for specified visits, sponsors should evaluate whether alternative methods for safety assessments could be used. This can include phone contact, virtual visits, and the use of alternative locations for assessments. Sponsors should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach.

“The need to put new processes in place or to modify existing processes will vary by the protocol and local situation,” the agency said. “For example, this assessment could include consideration of whether it is appropriate to delay some assessments for ongoing trials, or, if the study cannot be properly conducted under the existing protocol, whether to stop ongoing recruitment, or even withdraw trial participants.”


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