- Enrollment in clinical studies in the U.S. is on the rebound following the disruptions caused by the COVID-19 pandemic.
- Still, a fresh surge of coronavirus cases could once again scramble studies aimed at testing disease treatments.
- At international level, countries like France, Italy and Spain have returned to baseline enrollment levels as the COVID – 19 caseloads have normalized.
- Yet, the patients and doctors face hardship as most of the research trial centers fear the spread of coronavirus.
- To overcome this situation, telehealth platforms, web-enabled devices, organized follow-up blood tests and independent clinics rather than at research institutions are followed.
A recent news published in the ScienceMag, written by Eli Cahan reveals the tough times faced by the clinical research institutes, and the new paitents, who wish to enroll in the clinical trials for various disease treatments. The hardships are mounting making the clinical trials near impossible at the research centers due to amuck caused by coronavirus.
Uncertainty looms but hopes around
What if the scenario continues? Who are the most affected in this pandemic connected to the clinical research trials? and What are the possible ways to overcome this sudden unprecedented turn of events in medical history? The answers for these questions are as follows.
Clinical trials down
- In June, engagement of new patients in U.S. clinical trials was down 38% compared with prepandemic levels.
- That’s still a significant improvement from April, when U.S. enrollments were much lower: down 70% at the 1500 trial sites tracked by the firm.
- Some hospitals, including the Memorial Sloan Kettering (MSK) Cancer Center in New York City, New York University’s Langone Health,
- And the medical center at the University of California, San Francisco (UCSF), have reopened almost all of their trials.
A ‘new normal’ for clinical research
Investigators and sponsors have taken exhaustive efforts to “future-proof research … [by] reinvent[ing] the whole logistical side of trials,” says Bill Byrom, vice president of product strategy and innovation at Signant Health, a clinical trials support platform.
The new normal begins
Trial operators distribute equipment to protect research staff, and make it easier for patients to reach trial sites by coordinating private transportation.
To protect trial participants, operators arrange for shipment of trial medications directly to them.
Facilitate virtual monitoring through web-enabled devices and telehealth platforms, and organize follow-up blood tests and other trial assays options in community settings such as independent clinics rather than at research institutions.
Not any more traditional clinical trials
“These aren’t your parents’ clinical trials anymore,” says Kent Thoelke, chief scientific officer at PRA Health Sciences, a contract research organization serving thousands of trial sites around the world. “We’ve virtualized the entire process.”
Most of the trial centers undergo change
It’s not just well-resourced trial centers that are making changes.
Nearly two-thirds of research sites have adopted telemedicine in some capacity to conduct trials during COVID-19. Before the pandemic, only about one-quarter of sites used virtual practices.
Cancer centers adapts change quickly
Cancer centers across the United States have sought to be particularly “nimble” because of the potential vulnerability of their patient population to COVID-19, says Michael Carducci, a prostate oncologist and associate director for clinical research at Johns Hopkins University’s (JHU’s) cancer center.
Remote visits and other decentralized practices have become the “new normal” of clinical research, he says.
Concerns from pharmaceutical sponsors
Nonetheless, the 38% enrollment shortfall reported by Medidata indicates that struggles persist.
Some institutions, like JHU’s Kimmel Cancer Center, are still facing concerns from pharmaceutical sponsors about dropping certain traditional practices, such as in-person physical exams.
Other institutions, including Columbia University’s Irving Comprehensive Cancer Center, have imposed hiring freezes that have led to enrollment constraints because of reduced staffing. These factors—among others—have forced trial delays and postponements.
Limited options for some patients
For patients who undergo treatment for incurable diseases through conventional therapies —such as end-stage cancer patients—loss of access to clinical trials implies “losing an important aspect of their care,” says Ezra Rosen, a breast oncologist at MSK.
Trial therapies can make a big difference
Although experimental medications are by no means guaranteed to be effective—fewer than 10% of drugs in phase I safety trials prove effective, and some 40% of drugs that advance to phase III efficacy trials fail—for some patients, “trial therapies can make a massive difference … [and] they can be life-altering,” Rosen says.
Less choices for patients with deadly disease
The pandemic has reduced choices for some patients facing deadly diseases, says Chloe Atreya, a gastrointestinal oncologist at UCSF.
One of Atreya’s patients, Nathan Kelly, was diagnosed with stage 4 colon cancer in January 2018. His cancer was not responding to first-line chemotherapies and he enrolled in a trial testing two novel monoclonal antibody drugs. But those medicines also didn’t work.
He elected to wait, hoping a second-line chemo regimen could “keep the cancer at bay.” Within 3 months, it became clear the regimen was ineffective, but by that time the two trials had stopped enrolling patients because of COVID-19.
Atreya is worried, too. “It’s a race against the clock right now,” she says.
Will the U.S. climb back to prepandemic clinical trial enrollment
Whether researchers in the United States will fully climb back to prepandemic clinical trial enrollment will depend, in large part, on regional COVID-19 caseloads.
- As states such as Texas and California have reinstituted lockdowns in recent weeks because of mounting caseloads.
- They either recommend—or require—hospitals preserve bed capacity for COVID-19 patients. That means once again restricting other visits, including those for clinical trials.
The White House warns
The White House this week reportedly warned 11 cities in other states, including Baltimore, Cleveland, Indianapolis, Las Vegas, Minneapolis, New Orleans, Pittsburgh, St. Louis, and Nashville, Tennessee, that they will need to take “aggressive” action to limit coronavirus infections to protect their health care systems.
Doctors involved in research trials are watching these developments warily. “With a certain sequence of events in next few weeks,” Rosen says, “we could be back to square one.”
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Source: ScienceMag
