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From Our Experts: Sami Abate, PhD, MSHS, MSN, RN, CCRN
In the landscape of the COVID-19 pandemic, clinical trials are coming up in conversation more frequently. Sami Abate, PhD, MSHS, MSN, RN, CCRN, Inspira Health's Director of Research and Nursing Quality clears up some of the common misconceptions and breaks down their importance.
What are clinical research trials?
Clinical trials are the science behind new medications, new treatments, new therapies and new devices that are coming out all the time. The clinical trial is the investigation phase in the lifecycle of a medication or treatment.
Are clinical trials safe?
By the time we bring these studies to our patients they've already been through pre-clinical phase. These medications have already been approved for study by the FDA. Any study, before it gets to a human, has to be approved by a governing body referred to as an Institutional Review Board (IRB). They look at every clinical trial, whether it's happening nationally or around the world to make sure they are safe for people.
How did the current COVID-19 vaccines in market get approved so quickly?
These vaccines were approved through an Emergency Use Authorization (EUA). EUA's allow the FDA to strengthen the nation's public health protections against public health emergencies through the use of countermeasures, like vaccines.
How is Inspira supporting scientific discovery through its clinical research?
We have probably over a dozen clinical trials running right now here at Inspira. We have trials that are looking at everything from low testosterone to cervical spinal fusion surgery, and everything in between—diabetes, cholesterol, COVID-19 and numerous cancer studies. We even have a clinical trial that is looking at the impact of COVID-19 on cancer patients.
Why are clinical trials important?
We are creating science. We are creating knowledge that will guide practice in the future. If we don't have clinical trials, if we don't have research, if we don't have science, we have opinion—or conjecture. Some of the best ideas out there, they are just ideas, they're just imaginations, they're just dreams until you do the science to prove whether they work or not.