Health Technology Assessment_ Using Biostatistics to Break the Barriers of Adopting New Medicines (2015)

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Before any new drug can be tested in humans, regulatory authorities throughout the world require some non-human testing. These tests can be on tissue, lab animals or data gathered in previous studies for the same drug used in a different way. If the drug passes this early stage without safety concerns and shows promise of providing benefit, then testing can begin in humans and proceed through the four phases (U.S. Food and Drug Administration 2014).
In Phase I, the new drug is given to a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify side effects. In Phase II, the drug is given to a larger group of patients to see if it works well, to find the optimum dose that provides maximum benefit and to further evaluate its safety. In Phase III, the drug is given to a large group of patients to confirm how well it works compared to commonly used treatments, further monitoring of side effects and collection of detailed information so that the drug can be prescribed and marketed safely. And finally in Phase IV, further studies are conducted after the drug has been approved for the market to gather information on the drug’s effect in various populations and any side effects associated with long-term use. Drugs can be offered to the market based on successful Phase III trials, sometimes Phase II trials, but sometimes requiring ongoing Phase IV trials.

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