With the obvious exception of the more than 135 worldwide trials of COVID-19 treatments and vaccines, virtually no new clinical trials have been launched in the United States since the pandemic was declared a public health emergency in early March. Many ongoing trials have also been put on hold, noted experts in AVBCC’s August 14 webcast on research and investigational studies in the COVID-19 era, moderated by Swim Across America CEO Rob Butcher.
“About 35% of ongoing clinical trials in the US were on hold as of April, and that percentage has grown significantly since then,” noted Denise McDade, Vice President of Quality & Regulatory Affairs for Lightship, an enterprise provider for direct-to-patient clinical trials. “The FDA also authorized sponsors to halt previously required phase 4 postmarketing trials without completing them. The trials that have been continuing are mostly in rare diseases and oncology.”
As the FDA has suspended regulations like interstate telehealth licensing requirements and granted a flurry of Emergency Use Authorizations for drugs, manufacturers sponsoring clinical trials have also responded by lifting burdensome requirements, allowing direct-to-patient shipment for drugs that do not require tight temperature control, implementing remote informed consent, and switching to local labs for monitoring that have more capacity than those at besieged medical centers.
Ms McDade predicted that direct-to-patient trials—which recruit patients “in the wild,” rather than the existing model centered almost entirely on recruitment from medical practices—will continue to grow after the pandemic is over, addressing many challenges to study recruitment and retention.
“These trials put the patient at the center of the ecosystem,” she said. “If you’re on a trial at Lightship, you download an app onto your phone—if you don’t have a phone, we send you one—and that’s your primary mechanism for communication about the trial. Secure telemedicine is used for almost everything, study drugs are sent through the mail, and even if a procedure needs to be done, we can send a nurse or other provider to the home to do things like getting blood samples.”
Even before COVID-19, investigators at MD Anderson Cancer Center in Houston had been trying to find solutions to barriers to trial enrollment, such as cost, time, and burden of travel to patients, said John de Groot, MD, Professor of Neurology and Chair of the Department of Neuro-Oncology.
“In neuro-oncology, we really struggle with putting patients on trials. Fewer than 10% of patients with high-grade gliomas are in clinical trials,” he said. “So although we have also experienced a decline in clinical activity and trial enrollment, we have learned important lessons about moving many of the things we were doing in person to virtual. Virtual interactions are acceptable for trial consenting, monitoring, and management. You do need a local provider to see the patient, however—particularly with neurologic disease—there are a lot of things you can’t see or do over a camera. Study sponsors are also now more amenable to allowing local healthcare providers to become subinvestigators for things like study-specific assessments. These changes offer opportunities to improve our accrual in neuro-oncology.”
Pediatric oncologist Robyn Gartrell, MD, Assistant Professor of Pediatrics in the Division of Pediatric Hematology/Oncology at Columbia University Irving Medical Center, reported that although her group is unable to enroll new patients in clinical trials, they have continued to make progress in research on novel strategies to treat pediatric cancers. “My research focuses on bringing the successes from immunotherapy in adults to children,” she said. “We are primarily working from home now, and it seems that we have had more creative thinking that has led to new collaborations and novel projects that might not have happened if we had been continuing with our everyday hustle and commute.”