How clinical research coordinators run COVID trials

Clinical trials have always been a centerpiece of how medical research moves forward to establish that new treatments are safe and effective. This year, as COVID-19 spread from country to country, clinical trials for treatments and vaccines for the new coronavirus drew massive public attention. Trials were launched in record time throughout the world, including more than a dozen at Penn Medicine investigating COVID-19 testing, treatment, and vaccine development. 

Medical professional wearing PPE using lab equipment in a lab.

“The number of cases was increasing and patients were critically ill,” says William R. Short, associate professor of clinical medicine in the Perelman School of Medicine, who is the principal investigator (PI) on a trial investigating the anti-viral medication remdesivir, sponsored by the National Institutes of Health. “The foot was to the pedal to get a treatment, something to offer patients.”

And behind every trial, there was a huge team effort that is often largely unseen. Clinical trials in the news often focus on the study’s PI—the research physician who leads the trial. But the PI is only the tip of the iceberg. Behind the scenes of any clinical study is a team of dedicated employees who keep the operations running smoothly. At Penn Medicine, there are approximately 1,000 clinical research staff, including clinical trial regulatory staff, clinical research assistant and nurses, and clinical research project managers and directors.

Research coordinators oversee everything that’s required to keep a clinical trial adhering to strict regulations. They make sure the PI gets the daily notes done, that patients get the correct medication at the right dosage—and all the necessary labs drawn—at the right times. Coordinators even make sure that tubes are readily available to collect the samples. 

Their work has always been essential to the successful outcome of studies, but the COVID pandemic brought new urgency to these responsibilities. In response to the needs of the crisis, clinical research staff from across Penn Medicine stepped up in new ways to coordinate COVID-related clinical trials, learned new ways of doing their jobs, and have proven to be key unsung heroes of the coronavirus response.

This story is by Sally Sapega. Read more at Penn Medicine News.