March 31, 2020 -- When patients with terminal diagnoses run out of hope, they often turn to clinical trials for one more “Hail Mary pass” at a successful treatment or cure.
Many in this situation have been extremely anxious over the last few weeks, with COVID-19 fears on top of the anxiety of having a fatal illness. Then they began to worry that their clinical trial would be canceled.
The good news is that most companies and researchers seem to be continuing trials for life-threatening conditions. The bad news: Most studies not considered critical are being deferred. This won’t have much effect in the short term, but if this continues, it could delay patient care and the federal approval of drugs that treat a wide range of conditions.
At Dana-Farber Cancer Institute in Boston, roughly 10% to 20% of patients are taking part in clinical trials at any one time.
“We consider the treatment through clinical trials as part of the therapy, and oftentimes, it is the best therapy for people with cancer,” says Bruce Johnson, MD, chief clinical research officer for the Harvard-affiliated institute.
He says patients will continue to be placed on trials as long as Dana-Farber has enough of the drug being tested, the patient can travel as needed for treatment and checkups, their doctor can monitor them for side effects, and there are enough healthy doctors and nurses to provide that care.
“I registered someone yesterday,” Johnson says. “We haven’t taken anybody off a study because of problems so far.”
The institute has shut down studies that don’t involve treatments that could be life-saving. And it’s too soon to tell, Johnson says, whether fewer patients are volunteering for clinical trials. “We’re looking at this multiple times a week to make sure we can continue to do this safely,” he says. “This information is unfolding by the day.”
Major Drug Companies React
Like many companies, Eli Lilly, of Indianapolis, recently announced it would delay the start of most new studies, pause enrollment in most ongoing studies, but continue clinical trials for patients who are already enrolled.
Biogen is “continuing the clinical trials we have underway in sites across the globe,” according to an email from a spokesperson. “We are monitoring this dynamic situation closely and expect that COVID-19 precautions may impact the timeline of some of our trials, particularly those that are actively enrolling and monitoring patients.”
Other companies have similar policies, with most delaying recruiting into new or ongoing trials -- to avoid putting any burden on health care facilities and doctors during the pandemic. At Pfizer, for instance, studies for patients with life-threatening conditions will continue, the company told Reuters. Bristol Myers Squibb has said that it will not start any new trials or add trial sites until at least April 13, though it will continue most research trials that have already begun meeting with patients.
Testing Returns to China
The best place in the world for clinical research right now appears to be China.
COVID-19 apparently originated from a market in Wuhan, China, that sold meat from wild animals, including the pangolin, a scaly creature resembling an anteater. The virus exploded from there, infecting more than 80,000 people in China, mostly in the province that includes Wuhan, but also in other hot spots across China, before taking off across the world. But China, as well as other Asian countries, have been largely successful at bringing their epidemics under control over the last month.
Now, companies like Swiss pharmaceutical giant Novartis are seeing Asia as a place to do clinical trials.
“Through the end of February, we were actually rotating and moving patients away from China and looking at moving those patients in terms of recruitment to Europe and the U.S.,” says John Tsai, head of global drug development and chief medical officer at Novartis. Now, the company is rotating its clinical trial recruiting back to Asia and China; Pfizer and Merck also said they are resuming research trials in Asia.
“I won’t say we’ve not been impacted by COVID-19, but what it has allowed us to do,” he says, “is we’ve been able to come up with contingency plans of how we’d actually make changes along the way.”
About 240 of the company’s 30,000 drug trials were affected as of March 22, “which is not in the grand scheme of things that significant,” Tsai says. Similarly, only 645 people out of 93,000 taking part in trials worldwide had missed safety check-ins, he says.
Turning to Tech
The company has a digital platform that allows Tsai and other company executives to see the status of their trials and patients in real time. If they notice that new recruits are backing out of appointments in one area, they can quickly shift recruitment elsewhere, he says.
Novartis has also moved to at-home care and monitoring wherever appropriate, Tsai says. Quick check-ins can be done by video chat or phone; medication can be shipped to homes, instead of doled out by nurses.
In Wuhan during the worst of the outbreak, for instance, Novartis was able to continue a trial of the breast cancer drug Kisqali (ribociclib). The company tracked down participants’ home addresses through their databases and used couriers to get them their drugs within a week, “so we wouldn’t have any drug interruptions,” Tsai says.
He says he sees the crisis as an opportunity for those who do clinical trials to streamline the process. Novartis is now helping the Gates Foundation set up a similar electronic system for its ongoing trials.
“I think this has been a really good learning case for the entire industry,” Tsai says.