post-title Medical Research: What is it? Who would ever volunteer for THAT? Maybe it deserves a second look…… 2013-01-28 16:59:58 yes no Posted by

Medical Research: What is it? Who would ever volunteer for THAT? Maybe it deserves a second look……

by Dr. Don McNeil, M.D. Many people do not realize that a prescription medication that is recommended by their health care provider was proven to be effective only because it was studied vigorously in a clinical trial. Most over the counter medications are required to have passed similar studies. Perhaps these same people have heard […]

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by Dr. Don McNeil, M.D.

Many people do not realize that a prescription medication that is recommended by their health care provider was proven to be effective only because it was studied vigorously in a clinical trial. Most over the counter medications are required to have passed similar studies. Perhaps these same people have heard that it takes many years and a great deal of money to develop these drugs but they did not consider that a clinical research trial is required by the Federal Drug Administration (FDA). In fact, the FDA requires multiple trials which is outlined below.

There are three categories of clinical research trials. Phase I studies are intended to study the risk of potential side effects from a candidate medication. The drug will not have been given to a human volunteer before but it will have been studied in depth in a laboratory setting as well as in other animal models such as in mice, rats or other mammalian species. The human volunteers are usually healthy young subjects who will be introduced to the study medication in small doses. The dose is designed to be so low as to have no clinical effect. A typical phase I study will involve 4 or 5 young healthy males or females who volunteer to live in a residence for 3 or 4 days. During that time, they will be given the study medication while careful analysis is carried out and includes monitoring kidney, cardiac, respiratory and neurologic function.

Phase ll studies are larger and requires the drug be given to individuals with the target illness. The drug may still be given in doses often too small to have an effect on the condition under investigation but the dose is higher and more likely to show benefit while it is still followed closely for side effects. Phase ll studies are conducted in a few clinical sites and usually in several locations around the country or in other countries.

Phase lll studies are carried out in many clinical centers such as Optimed Clinical Research which is affiliated with Midwest Allergy and located immediately above the office on Ravines Edge Court. These studies involve many subjects with the target illness and using the dose or doses that are considered to be beneficial. Volunteers for these studies are provided with all the information available about the medication, the opportunity to ask any questions they may have or to just take more time to consider joining in the study.

Dr. McNeil is an allergist and immunologist at Midwest Allergy, as well as the Primary Investigator at Optimed Research.

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