FDA Issues Guidance on Conducting Clinical Trials During COVID-19

FDA recently announced that it issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 pandemic.

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The coronavirus pandemic has the potential to impact the conduct of clinical trials of medical products, including drugs, devices, and biological products. 

Challenges are bound to arise, including from quarantines, site closures, travel limitations, interruptions to the supply chain, or other considerations, especially if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19.

“The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19,” the FDA stated in a recent press release. 

FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.

The guidance advised sponsors to converse with institutional review boards and independent ethics committees about all urgent changes necessary due to COVID-19. Sponsors need to be able to explain why the protocol changes are necessary and the ways patients may be impacted. 

In-person visits with trial investigators and other standard monitoring procedures may not be practical for many patients, especially during the pandemic. Sponsors should consider alternative monitoring methods, including virtual teleheath visits, switching to local imaging centers, and using remote monitoring programs.

Additionally, alternative methods of administering the investigational products, including home nursing aides or at alternative local sites, is recommended if care is disrupted.

“Sponsors, clinical investigators, and IRBs should consider establishing and implementing policy and procedures, or revise existing policy and procedures, to describe approaches to be used to protect trial participants and manage study conduct during possible disruption of the study as a result of COVID-19 control measures at study sites,” FDA noted in the guidance.

But patient safety should always be at the forefront, Anand Shah, MD, FDA Deputy Commissioner for Medical and Science Affairs stated.

Other considerations recommended include, among others, evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site.

“The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” he said.  “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.”

As healthcare companies work around the clock to develop a potential COVID-19 vaccine, some clinical trial sites are quickly becoming more concerned about COVID-19-related interruptions to clinical trial recruitment and retention. 

US clinical trial site concerned increased from 25 percent to 47 percent over a period of four days. This is an 88 percent increase during the short timeframe.

“We are seeing an unprecedented shift in site sentiment over a very short time frame,” said Paul Ivsin, Continuum vice president of data and analytics. “We need to continue monitoring these trends and building fact-based planning scenarios to help sites and sponsors prepare for a period of very different patient recruitment and retention patterns.” 

Continuum Clinical emphasized that it will continue to publish updated data to track how the current situation unfolds in the coming weeks and provide global data and real-time updates as they are available.