The recent disclosure that the President of the United States was treated for a life-threatening illness with a relatively untested medicine has put a spotlight on clinical research and the processes for allowing expanded access to experimental drugs during a time of crisis, says Clint Hermes, counsel with Bass, Berry & Sims PLC.
“President Trump received a ‘cocktail’ of drugs as part of his treatment [for the coronavirus] and [some] of the drugs weren’t approved” in the traditional clinical trial process, Hermes notes. As part of the aggressive treatment earlier this month, the president received a dose of an experimental drug only tried so far in about 2,000 people as part of a research trial.
The COVID-19 era has put a “tremendous” pressure on clinical trial professionals to rush drugs and other treatments to market to help people who are scared and “desperate” as they face a potentially life-threatening illness, Hermes says. Now more than ever it is important for clinical trial professionals to be able to “navigate this weird boundary between clinical research and expanded access,” he adds.
“Emergency use authorizations don’t happen very often,” Hermes notes. They tend to be reserved for medical emergencies such as COVID-19, the Zika virus, or anthrax scares, he explains.
During these times of COVID-19, Hermes says, vaccine trials and related treatments are “floating in and out of different pathways” of development, including clinical trials. It can be a confusing situation that requires clinical trial professionals to stay abreast of current regulations and best practices.
For example, the U.S. Food and Drug Administration (FDA) issued an important guidance on March 25 saying that, “in light of the need to act quickly and efficiently to respond to the COVID-19 public health emergency… FDA anticipates it will issue COVID-19 related guidance documents for immediate implementation without prior public comment.”
“These are unprecedented times,” Hermes says, and it’s vital for clinical trial practitioners, especially those involved in regulatory affairs and those working in academic medical centers, to be at the very top of their game in terms of understanding current regulations and expectations, he says.
Author: Michael Causey