While researchers worldwide race to find therapeutics to fight the coronavirus pandemic, there’s a firm right in Princeton that’s paving the way.
WIRB-Copernicus Group, a company that markets solutions that make clinical trials run more efficiently, has been trying to help in the development of potentially life-saving medications and vaccines for COVID-19, the disease that has now spread to more than 100 countries. As part of that, the business, which also goes by the acronym WCG, is prioritizing review of this research and waiving some of the usual fees for getting trials underway.
All the attention is on speeding up these hoped-for cures. And, at the same time, other, unrelated medical research might be slowing down.
“Researchers are really in uncharted territory right now,” said Lindsay McNair, chief medical officer for WCG. “We’re still figuring out all the implications of this.”
One thing’s for sure: Clinical trials that aren’t addressing the current pandemic are nonetheless being shaped by it. Research that’s either underway already or in the planning stages is already having to be heavily modified to protect the safety of clinical trial participants, given how infectious COVID-19 is believed to be, according to McNair.
“Some are sending nurses to homes, using local laboratories instead of hospitals … doing visits by telephone,” she said. “If the research requires study participants to come into the hospital setting, researchers have to now put processes in place for screening people for COVID-19.”
That’s assuming researchers even choose to continue with the study. Many clinical trials are being put on hold.
“There are centers putting a pause on any studies that don’t have potential direct benefit for participants, such as a review of drug interactions in healthy people or an observational study that involves long-term follow ups,” McNair said.
ROI-NJ spoke to McNair the day the Food & Drug Administration released guidance on the conduct of clinical trials during the pandemic. She said it was consistent with advice WCG had already been providing to researchers.
It’s too early to say what sort of impact these last-minute changes or pauses to medical research will have in the long run. For now, the protection of participants has been paramount and weighed above other concerns among researchers, McNair said.
As far as research directly related to COVID-19, McNair said WCG has already seen a number of early clinical trial protocols submitted, including vaccine research or studies of proposed therapeutics.
One example was a research protocol submitted by Vir Biotechnology Inc., a clinical-stage immunology company. WCG put the protocol at the top of its queue and then performed an institutional ethical review required before research can begin.
Vir Biotechnology’s chief medical officer, Phillip S. Pang, said this was critical to the rapid start of the study, which is designed to collect blood from patients who have recovered from the disease to potentially isolate antibodies.
“It took only 48 hours from submission to approval — at a time when every day may count,” he said.
WCG, and the researchers it supports, are just getting started.
“My hope is that we’ll be able to play important role in trying to facilitate the startup of these studies … streamlining them in a way that’s scientifically rigorous,” McNair said. “And, of course, we want them conducted ethically as well — we’re not talking about rushing anything the process through that shouldn’t go through.”
Reach WCG at: 609-945-0101 or visit wcgclinical.com.