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September, 05 2024
RESPIRATORY HEALTH
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Discussing Pharma Clinical Trials Utilizing POC Diagnostics
Dr. Sher M.D. FAAP of Peninsula Research Associates discusses point-of-care diagnostics as integral to clinical trials.
Transcript
Dr. Sher M.D. FAAP: “Point of care diagnostics is probably one of the more important parts of a trial because if you can do it right there right then the study goes forward.
Trials for drugs that are being developed, those you’re taking a sick population, nothing else works, and they're begging for medications they need something to help them that we never have used before.
Vaccine trials are healthy volunteers that are wanting to be in the study because they want to prevent or even more so, many of the patients that are going the vaccine trials want to help everybody else.
Often a patient will come in, you to see if they meet the what we call inclusion criteria, and they don't meet what we call the exclusion criteria so often you'll need a diagnostic lab to meet the inclusion criteria. If you have to send out you're looking at 2 to 3 days to get the result and another 2 to 3 days to get the patients back in you're looking at a week at least. With the GeneXpert whether we're doing,you know, COVID, RSV it is a point-of-care system that we can use and get the results right away.
It's simple, which is number one from my staff, and you can get the results back depending on the test between 30 minutes and 60 minutes, and I'm able to give them absolute accuracy. When the pandemic started, we looked at every system. I am one that looks at the science. I am not one that looks at anything else but science. So you want to get a test that has the best sensitivity and specificity, and when you look at PCR, that's where you get the best results, and the science came down to the most accurate PCR was the GeneXpert, Cepheid.
We put in over a thousand patients for vaccination studies quickly. It was probably one of my most successful moments in terms of just how I felt in dealing with patients. I'm always trying to go the next step better to help whether it's my research facility or all the healthcare providers that work for me and the only way to do that is to have better ways to help the patients if you're going to give better care to the patient population you better have the better instruments that are going to do it, and so I went to a moderately complex GeneXpert system because it gives me so much more."
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