After her teenage daughter tested positive for the novel coronavirus last January, Jennifer Scruggs began disinfecting surfaces at her Bethpage, NY home. Then she realized that she couldn’t smell the Lysol she was spraying. “Uh-oh – that wasn’t a good sign,” she recalls. “So I got tested and was positive for COVID for sure.”
Scruggs, an administrative clerk at Northwell Health, a network of hospitals and clinics in Long Island, NY, heard that her employer was recruiting non-hospitalized COVID patients for a clinical trial. The aim was to find out whether famotidine, the active ingredient in the heartburn pepcid, could reduce the severity of the infection. Striving to contribute to science, Scruggs was thrilled to learn that she could attend without leaving home. Everything needed for the month-long study – pills, instruments to measure her breathing capacity and oxygen levels, a scale, fitness tracker, and iPad – was delivered to her doorstep. The measured values from the devices were transferred to the iPad via Bluetooth and passed on to the research team. Once a week, a phlebotomist in protective clothing came to her home to take blood samples. “Honestly,” says Scruggs, “they made it very easy.”
In the first few months of the pandemic, medical research was radically interrupted for safety reasons. In the first five months of 2020, according to an analysis, almost 6,000 clinical studies unrelated to COVID were canceled, around twice as many as usual. But the outbreak has also accelerated the shift towards digital and remote research methods that make it easier for patients to participate and more efficient data collection for scientists. The study designs are being revised in various disciplines in order to make the study accessible to the patient and not the other way around. Scientists also hope to show that sluggish processes that have long kept people from participating in cutting-edge research can safely be streamlined for a post-pandemic era. “One lesson from COVID is that it can be done quickly,” says cardiologist John H. Alexander, a senior faculty member and researcher at Duke University’s Clinical Research Institute.
The experiments started last year already reflect changed practices. The original plan for the famotidine study was to take the participants to a clinic. “However, we knew that patients recovering from COVID at home would want to have their last blood test or follow-up exam. So we’ve completely revised our protocol, ”said Christina Brennan, Vice President of Clinical Research at the Feinstein Institutes in Northwell.
Alexander is co-directing a much larger, fully virtual study comparing two anticoagulants in people with artificial aortic valves. The patients are completely recorded and observed at some distance by researchers at 56 locations. “Everything is done over the phone,” he says.
Thousands of studies were ongoing at the MD Anderson Cancer Center in Houston when the pandemic broke out. It wasn’t possible to change the approved protocols, but attendee registration and some research-related visits have shifted to phone or video conferencing, says Jennifer Keating Litton, vice president of clinical research. “The big thing we’d wanted for years was remote consent setup. Now patients can do this on their phone and sign all consent forms. “
José Baselga, head of oncology research for pharmaceutical company AstraZeneca, sees COVID as a catalyst for far-reaching changes in cancer research. Studies often call for unnecessary hospital visits and tests, he says. For example, “There’s nothing written anywhere that you have to do in the lab every three weeks,” but it’s the norm. Baselga believes that not only will it be more convenient, but also safer, to rely more on remote monitoring of heart rate, breathing and other physical functions, as well as daily reports from patients about pain, appetite and symptoms. “Instead of waiting for them to show up in the emergency room, sick and painful, we can intervene beforehand,” he says.
Alexander, co-chairing the Clinical Trials Transformation Initiative, a public-private partnership designed to improve the quality of medical research, has pushed for such updates in medical research. “If we could make it easier and less duplicate to participate in trials, we would have more participation,” he says. For example, why do patients need to come to separate research-related visits? Why not collect research data when it comes to normal care? But making big changes means facing firmly anchored infrastructure, and he fears that progress will slow down after the pandemic ends. Baselga is more confident: “There is no way we will go back to the ‘good old days’.”