Makers of medical devices and prescription drugs will gradually pause U.S. Food and Drug Administration noncritical clinical trials amid the new coronavirus pandemic, according to two health-care attorneys.
The health-care industry is bracing to postpone tests on novel medical products because so many providers are being diverted to help treat patients of Covid-19, the disease caused by the new coronavirus.
“Those running the studies have to not only be an appropriately trained health-care professional but also trained in clinical trial requirements, which is limited right now because all hands are on deck to help with Covid-19,” Sonali P. Gunawardhana, a counsel who covers medical device regulation for Shook, Hardy & Bacon LLP and a former FDA attorney, said.
“Even if you’ve got seasoned nurses and seasoned doctors that are free, that doesn’t necessarily mean that they understand the clinical trial protocol,” she added.
That doesn’t mean all clinical studies will immediately halt. But already, ongoing trials face disruptions such as site closures, quarantines, travel limitations, and supply chain issues that could lead to shortages of the investigational drug or device, according to the FDA.
“The question of how clinical trials are going to continue to operate is clearly a significant issue,” Kirk J. Nahra, a privacy and cybersecurity partner at WilmerHale in Washington, said. “Companies and research entities are taking steps aggressively to ensure that safety of both the patients and the health-care workers is maintained in the operation of these trials.”
Heart Pump Trial Halted
Impella heart pump maker Abiomed Inc. announced Wednesday that it delayed a randomized trial studying heart attacks when a coronary artery is completely blocked and a large portion of the heart muscle is unable to receive blood.
The study explored the safety and risks of the Impella heart pumps and whether the use of the device reduced threats of future heart failure.
Abiomed plans to restart the study in about eight weeks when physicians and hospitals can enroll patients and record clinical metrics and will continue manufacturing and shipping Impella heart pumps and providing clinical support to patients.
Trials for Covid-19 treatments are the exception. Scientists will continue to do them as long as they can ensure the patients and health-care workers are safe, Gunawardhana said
“The FDA started running clinical trials on a vaccine to treat Covid-19, and they’re also taking plasma from survivors of the disease and are trying to see if that’s an option as a treatment,” she said. “Where there are trials ongoing that could address the issue, the FDA and manufacturers are going to try to continue to do those as long as they can do them safely.”
Stick to Protocol
The FDA already moved to help drug and device companies manage their clinical trials during the pandemic. It announced changes in protocol in a bundle of suggestions issued March 18. Those included a recommendation for companies managing studies to consider alternative methods to carry out tests, such as through phone contacts or virtual visits.
The guidance also allows scientists to change their studies in order to save the lives of research participants without first seeking clearance from ethics boards known as institutional review boards that typically approve clinical studies before anyone is enrolled. The boards must be notified after the changes are made, however.
The review board process, which can take up to two months, typically requires significant documentation and testing to ensure patient safety during a clinical trial, according to protocol guidance. That process becomes trickier in a pandemic or other emergency, when patients become reluctant to leave their homes.
“You have people who are afraid to leave their house and aren’t even looking to enroll in a clinical trial,” Gunawardhana said.