The U.S. Food and Drug Administration (FDA) issued guidance for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic, the agency recently announced. The agency is exhibiting a pragmatic sense of urgency, sharing with those conducting clinical trials the federal authority’s understanding of the extreme conditions now faced by the nation. The FDA seeks to keep clinical research going and is offering a level of flexibility to work with sponsors to manage how clinical trials may be impacted by changing conditions on the ground.

Challenges Associated with this Pandemic

The agency recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, such as drugs, devices, and biological products. They indicate that considerable challenges could manifest—for example, involving quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other material factors if investigator site personnel become infected with SARS-CoV-2.

The Implications of the Challenges?

Sponsors and sites may face increasing difficulty in conducting clinical research in the form of clinical trials. Hence, the FDA reports that for example, multiple protocol modifications may become necessary and there may be unavoidable protocol deviations during this crisis. The impact on trials will vary depending on a number of elements and factors—from the nature of disease and study, the trial design, the region, etc.

Hence the FDA introduces Considerations for Sponsors

Due to the implications of material changes to a protocol or a study itself due to this crisis, the FDA introduces considerations that sponsors can base decisions on moving forward—all in the spirit of maintaining compliance in furtherance of assuring the safety of trial participants, maintaining compliance with good clinical practice (GcP) and minimizing risks to trial integrity.

What are the FDA’s Considerations?

The FDA suggests that sponsors evaluate alternative methods for assessments, such as phone contacts or virtual visits and offering additional safety monitoring for the trial participants who may no longer have access to investigational product or the investigational site.

FDA Comment

Anand Shah, MD, FDA Deputy Commissioner for Medical and Scientific Affairs declared “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.” Dr. Shah continued, “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.”

About the FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Call to Action: See the link for the Guidance document. 

Source: U.S. Food and Drug Administration

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