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December 29, 2006, Newsletter Issue #35: An Explanation Of Clinical Trials
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Tip of the Week
There are four types of clinical research trials conducted on new drugs or medication. The first type of clinical research trial is known as a Phase I trial. It is completed to test the effect of a new drug on a small percent of the population, and is done on healthy individuals. The purpose of Phase I trial is to confirm a new drug's safety for human consumption.
Phase II clinical research trials are more beneficial to ALS treatment than Phase I research trials. The new drug will be tested in ALS patients to future determine its safety, and the benefits of the drug.
Phase III clinical trials are completed in specific ALS research facilities using a large number of ALS patients. Phase III clinical trials will investigate whether the new drug actually possesses the benefits found in Phase II. These benefits are tested against a placebo or another treatment, which is already in place. If Phase III trials are successful, the new drug is prepared for FDA approval. FDA approval is a lengthy process, and there is no guarantee any new drug will be approved.
Phase IV clinical research trials occur after the new drug is approved by the FDA, and during this phase, the pharmaceutical company must monitor and test the safety of the drug in the general population.
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