Pandemic disrupting clinical drug trials
Some studies continuing with modified research methods
When COVID-19 restrictions were put into place, many Bay Area residents mourned the sudden loss of the local restaurant scene. But for Julie Murphy, a public health librarian from Emeryville, a severe digestive disorder has long kept her from enjoying an evening out for dinner.
Her hopes for the future are pinned on a clinical trial she’s participating in that’s testing an aggressive new application of lovastatin, a drug traditionally used to treat high cholesterol. During a pandemic, however, that study looks very different.
The trial is hardly the only one affected. An analysis by this news organization of data on clinical trials from the National Institutes of Health found that the pandemic has led to the suspension of at least 60 trials and the disruption of hundreds of others in the greater Bay Area since March 1, stunting research into cancer, strokes, diabetes and other diseases.
“The impact has been profound,” said Harold Collard, associate vice chancellor of clinical research at UC San Francisco’s School of Medicine. “It has postponed, delayed or shut down a large percentage of our ongoing clinical research. It’s been an unprecedented time for us.”
Clinical trials play a critical role in medical research. They’re needed to prove that new drugs and therapies are safe and effective enough to be provided to patients. The trials also are often the only way for patients to gain access to promising medications and therapies. And even when participants receive a placebo in “blind” studies, they benefit from additional health care provided during the research.
In some instances, Collard said, trials are considered part of standard care. Cancer patients, for example, often enroll in clinical trials so they can take experimental drugs at the same time they’re undergoing chemotherapy.
But with so much attention shifting to coronavirus research, many hospitals lack the space, protective equipment and personnel to continue more exploratory and less urgent treatments
and research. While some studies have simply ground to a halt rather than adapt their methods, others, like Murphy’s, have been significantly modified to allow research to continue.
At Stanford’s School of Medicine, no new treatment studies or clinical observation studies will be initiated aside from those related to COVID-19, according to spokeswoman Julie Greicius. Researchers are testing antiviral medications like remdesivir as well as interferon-lambda, a drug given to patients with mild COVID-19 cases to allow them to recover at home.
Similarly, UCSF has given priority to clinical trials
with direct applications to the pandemic or those that deal with life-threatening illnesses.
In an effort to keep as many trials running as possible, the U.S. Food and Drug Administration recently released guidelines aimed at helping clinicians adapt their research methods. The modifications include using telemedicine to limit unnecessary trips to hospitals as well as mailing equipment and medications to trial participants. Many hospitals also have established appeals systems that allow doctors to argue for a trial’s continuation.
But many researchers have chosen to suspend their trials because of the complications of accessing certain services during the pandemic.
Sonya Borrero, a physician
at the University of Pittsburgh School of Medicine, was heading a clinical trial with a hub in San Francisco. The study was aimed at testing the effectiveness of an online tool Borrero had designed to provide reliable information to low-income women considering a tubal ligation. Even though the study didn’t require in-person visits, Borrero made the call in early March to postpone the trial when many hospitals began classifying the sterilization procedure as “nonessential.”
Noting that tubal ligations are the main method of contraception for women younger than 50 and are particularly popular with low-income families, Borrero said her decision was heartbreaking but unavoidable.
“There’s been a major disruption to family planning services,” she said. And that’s “going to have long-lasting life impacts beyond the COVID pandemic.”
When the pandemic struck, Murphy was halfway through her clinical trial at Cedars-Sinai Medical Center in Los Angeles. She reluctantly boarded a flight for her last in-person visit on March 13, the same day President Donald Trump declared a nationwide state of emergency over the coronavirus.
“I was worried I wasn’t going to get a drug if I didn’t go for the appointment,” recalled Murphy, 54.
Ultimately, the trial’s researchers made sweeping changes that have allowed the study to continue. And they worked hard to make
the process simple for her.
Her latest check-in took place in her own home, where she received equipment and medication by mail with detailed instructions on how to carry out each test herself. Her final appointment will be at an Oakland clinic.
“I performed the test, popped it in the box, walked it over to FedEx — and that was visit four,” she said. “I want to complete this because that’s one more person who will have helped get this drug to market.”
While the shift to virtual and remote methods has made it easier and cheaper for her to participate, she said, there is something lost in the transition: the comfort of speaking with a doctor face to face about potentially frightening medical issues.
“I would not trade my first visit because I got to speak to the expert and ask him all my weird questions,” Murphy said. “I got access to this valuable expertise that I don’t think would work if the whole thing was telehealth in the future.”
As states begin the slow, halting process of reopening, the hope is that most of the suspended trials will be able to resume in the next weeks and months, although some will likely need to start over entirely. Researchers are deciding how to move forward.
“When we had to shut down, in some ways it was easier just because it was so much more black and white,” UCSF’s Collard said. “Opening up is a different story, and the timeline for that is really unclear.”