By Scott Meacham
For this third column in my series exploring the long-term impact of the COVID pandemic on the fields of clinical research, I drew on the experience and insight Dr. Stephen M. Prescott, president of Oklahoma Medical Research Foundation (OMRF). The pandemic has already been a disruptor with a number of changes that seem likely to become permanent.
“Many things have changed during the time of the pandemic,” said Dr. Prescott.” We have to accept that and find ways to make those changes fit into our business.”
For OMRF and many other research institutions, those adjustments—most of them welcome—include remote work, rigorous anti-contagion practices and rules in laboratories, expansion of telemedicine, and a relaxation of FDA approval standards.
“Think about a research institution like ours,” Dr. Prescott said. “We have conferences all the time, and lab group meetings, smaller departmental meetings, and institute-wide meetings. Scientists travel here from all over the world; that’s just the way we did things. We grew up with it that way, and never took a hard look. This forced us to do something different. We got institutional subscriptions to Zoom and conference apps. We have all been pleased and a little surprised. Anything you can do on the phone, you can do from a home office.”
However, with researchers, it is different. “Some of their work can be done remotely, manuscript writing and grant applications for example, but not that much. I don’t see that changing any time soon,” said Dr. Prescott. He expects stricter safety measures industry wide as well as increased redundancy and hypervigilance to further reduce the risk of contamination.
“If an institution had an outbreak or people get sick or had to be quarantined, it could shut down research,” he said. This will keep research institutions managing people and lab access conservatively, well into 2021 and beyond.
Dr. Prescott says that the pandemic has been a force of positive disruption with the explosion in telemedicine for patients and a “fast-path” mindset at the FDA. Now that insurance companies are paying for virtual visits, adoption of telemedicine has been dramatic industry-wide. OMRF sees a large percentage of research clinic patients online.
“People with autoimmune disorders have to be hyper-vigilant,” he said. “Making routine checks virtually has been a great thing for us and for all other practices.”
Another pandemic-positive, thanks to the drive for a COVID vaccine, is a bit of FDA relaxation in requirements for proving efficacy (the ability of a drug to produce a desired or intended result).
“There has been so much emphasis on sorting out efficacy before approval,” Dr. Prescott said, “when what consumers and patients really need is for the FDA to focus on the safety issues and let the marketplace sort out the efficacy. If a drug works, everyone will figure it out.” With the FDA taking that approach with COVID, the agency may become more comfortable with a similar model for other drug approvals over time.
As destructive and exhausting as this pandemic is in the near-term, it is encouraging to consider future positives for an institution and an industry that are a cornerstone of Oklahoma’s innovation economy.
Scott Meacham is president and CEO of i2E Inc., a nonprofit corporation that mentors many of the state’s technology-based startup companies. i2E receives state appropriations from the Oklahoma Center for the Advancement of Science and Technology. Contact Meacham at i2E_Comments@i2E.org.
