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Summary of Remarks
Mark Winnet, MBA
Adjunct Associate Professor, USP
Assistant Director, R&D Management Operations Centocor
March 14, 2007
Mark Winnett spoke in his capacity as a member of the adjunct faculty of the pharmaceutical business program at USP. He described the process of testing new drugs for safety. He explained that before a new drug is put on the market, safety is the primary concern in clinical trials. Phase I answers the question of whether or not the compound is safe for consumption. Phase II investigates safe and effective doses. Phase III looks for any potential unintended adverse reactions that the drug may cause.
Phase I
Only a very small group of people is needed for these exploratory studies. The group usually consists of roughly ten to twenty people. These studies are done to see if any level of exposure to a novel medication will be toxic to a healthy person. These experiments are searching for extreme events.
Phase II
If the potential drug does not cause any harm during Phase I, the patient population is expanded to about two hundred. During Phase II there is an expectation of positive pharmaceutical effect. Clinicians are also looking for hidden hazardous effects.
Phase III
After a drug has demonstrated efficacy, the patient pool is augmented to at least 1,500 patients. The group of patients gets larger with each phase in order to increase the confidence level of the statistical analysis. Another goal of this phase is to create an approved label for a physician to follow.
In closing, Mark Winnet emphasized that the public should understand that all drugs have some dangers and that no drug is safe. Many people assume that once the FDA approves a drug, they can use it without concern. This is not the case. A million experiments on a million people will never make a drug safe. The three clinical trial phases determine whether the effect of using a drug is more or less detrimental to one’s health than the disease that it could treat. Perhaps drugs should not be thought of simply as safe or unsafe, but as existing at a point on a scale of risk.
Adaure Akanwa
MS Student
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