Clinical trials aren’t known for their speed. For researchers like Washington University’s Dr. Stacey House, it can take months just to plan the studies. More time is needed to enroll patients, and that’s all before getting down to the science. After that? Add a couple of years before FDA approval even approaches the realm of possibility.
But in 2020, under the pressure of the pandemic, those usual timelines were crunched into a few short months as scientists at Washington University rushed to evaluate the COVID-19 tests that doctors needed to detect the disease. Ultimately, more than 6,000 local patients were involved in the university’s clinical trials of COVID-19 tests — and after the first test gained FDA approval, the process was repeated. And repeated.
In total, Wash U physicians worked on 24 different clinical trials for COVID-19 tests, from PCR tests designed to be administered by physicians to at-home rapid versions.
“Typically, we were enrolling 2,000 to 3,000 patients per year in all of our clinical studies,” House said on Monday’s St. Louis on the Air. “To have over 6,500 enrolled just in COVID diagnostic studies, in a year and a half to two years, was a big ramp-up for us.”
An assistant professor of emergency medicine, House served as the university’s principal investigator in clinical trials of COVID-19 tests. The trials drew on patients admitted to the emergency department of Barnes-Jewish Hospital.
At the onset of the pandemic, House explained, the lack of a standard testing regimen proved a significant roadblock to treating the disease.
“It's definitely been a moving target throughout the whole pandemic,” she said.
The at-home tests were particularly difficult to evaluate.
“The reality is that we're asking people to do tests who don't typically do any kind of testing at home,” House said. She explained that the research team eliminated patients with any kind of medical experience, even those who did glucose testing at home for diabetes. “We wanted truly naive patients,” she noted, “to be as safe as possible.”
The evaluations went beyond the chemical process of the COVID-19 test themselves, House said. “We had to do a lot of looking at the instructions for these tests, and thinking: ‘Is this readable? Is this clear and understandable? Should we have more illustrations of how the sample should be collected, and what the test results are going to look like?’”
House and her team of scientists only recently ended clinical trials on COVID-19 tests. Even so, she said the next stage of the research is already underway as scientists seek to create new diagnostic tests that can detect not just COVID-19, but also simultaneously screen for other respiratory diseases like influenza.
Looking back on the past two years, House emphasized the combined efforts of scientists and patients — working faster than anyone previously thought possible.
“A lot of people gave of their time to make this kind of thing happen,” she said. “The thing that I take away from it is, just look what we can accomplish in a short period of time if a lot of people pull together.”
“St. Louis on the Air” brings you the stories of St. Louis and the people who live, work and create in our region. The show is hosted by Sarah Fenske and produced by Emily Woodbury, Kayla Drake, Danny Wicentowski and Alex Heuer. Avery Rogers is our production assistant. The audio engineer is Aaron Doerr.
