Pamela Chiesi - The Phases of Human Clinical Trials

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Having worked in the biopharma space for more than fifteen years of her career, Pamela Chiesi has developed a high understanding of the various processes that must be undertaken to bring a product from concept to the market. One of the most important processes for a pharmaceutical product is human clinical trialing, which helps scientists gain a better understanding of the effects of a product on people and any side-effects that could be causes for concern. There are four main phases to human clinical trials.

Phase I

The studies related to this phase will assess the safety of the product and often takes a number of months to complete. Typically, researchers will construct test groups of healthy volunteers, typically ranging in number between 20 and 100, who are usually paid for participating in the study. The study itself will examine how the product affects healthy humans, playing close attention to how well it is absorbed, metabolized and excreted. It will also examine any side-effects that occur under higher dosages.

Phase II

The second phase is used to determine how effective the drug is, either when compared to other products of a placebo. This phase can last anywhere from a number of months through to two years and often involves large-scale studies where groups are split into those who are taking the product and those who are being given a standard treatment or a placebo. These studies will generally be “blinded”, so that patients and researchers are unaware who falls into which group. This guarantees the safety of the study and ensures that companies provide accurate data to the FDA.

Phase III

The third phase is, in many ways, an extension of the second. Assuming positive results in Phase II, similar studies will be carried out using much larger groups of people, often numbering in the hundreds or thousands of patients. These tests will be randomized and blinded, offering researchers a stronger idea of the overall effectiveness of the drug and any circumstances that could lead to side-effects developing. Upon completion of this phase, the company can request approval of the product from the FDA.

Phase IV

Pamela Chiesi notes that studies continue after the product has been brought to market. The data from the Phase IV studies will demonstrate the drug’s long-term impact on patients, how cost-effective it is, especially when compared to other treatments, and how it compared in terms of effectiveness to other products on the market.

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