FDA issues coronavirus guidance for clinical trials

The US Food and Drug Administration (FDA) issued the guidance “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. The agency issued the document after recognizing the virus, and efforts to stem the spread, could have far-reaching implications for the operation of clinical trials.

These difficulties may include quarantines, site closings, travel limitations or bans, supply chain interruptions, and considerations if site staff or subjects become infected.

David Borasky, vice president of institutional review board (IRB) compliance at WCG, told Outsourcing-Pharma that he finds while much of the guidance serves to reinforce regulations that already exist, that reinforcement is still helpful to industry professionals.

“It’s not a new process or rule, but it’s one that many people in research have never had occasion to use before and may not even have been aware of​,” he said. “The guidance is also helpful in that it reinforces that the safety of research participants should be the paramount concern, and that documentation of what is happening is essential to understanding the data later​.”

Anand Shah, the FDA’s deputy commissioner for medical and scientific affairs, said the guidance was issued to help site sponsors and staff navigate the challenges and confusions the coronavirus pandemic has created.

“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​,” he said. “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​,” Shah added.

According to the agency, coronavirus avoidance might dictate protocol modifications or cause unavoidable deviations from set protocol. These impacts may vary according to the nature of the disease at the center of a study, overall trial design, geographic location of the study and population, and other factors.

In the guidance, the FDA has laid out considerations designed to help sponsors protect the safety of trial participants, adhere to clinical best practices, and keep risks to trial integrity to a minimum. These include alternative assessment methods (such as phone calls or virtual visits) and offering additional safety monitoring options for participants who no longer can access the investigational product or site.

Additionally, the guidance recommends sponsors carefully record any modifications to protocol made in response to the impact of the pandemic. The guidance can be downloaded on the FDA website​.