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Clinical Trials Demystified 

By Michael Plontz
(Page 1 of 2)

It seems that every time you turn on the television or open a magazine these days there is a new drug being touted as the new miracle cure-all. This is especially true of allergy and heartburn medications. How do scientists and researchers know what works and what does not work? Potential new drugs are first thoroughly evaluated in the laboratory with computer models. After this phase of testing is completed, additional research is then performed on laboratory. 

Eventually, the new drugs must be tested on human beings. This is done in a process called a clinical trial. It may sound as though a research facility is being sued, but itís even more complicated than that.

It was in 1938 that the Federal Food, Drug and Cosmetic (FDC) Act was passed which made evidence of safety mandatory before marketing was possible. The Kefauver-Harris Drug Amendment passed in 1962, required that a drugís effectiveness, as well as its safety, had to be proven. The Food and Drug Administration (FDA) makes the final decision.

So what is the process? Clinical trials, also known as investigational drug studies, are a carefully designed research study to determine whether new treatments or drugs are safe and effective. These trials involve using people, but only after extensive laboratory and animal testing show positive results.

Clinical trial protocol is a set of rules on which the trial is based. Basic protocol consists of the following information:

    Who may participate

    Test, procedure, medication and dosage schedules

    Length of study

Each clinical trial proceeds through four phases. In Phase I, scientists test a small group of 20-80 people for the first time. A procedure or drugís safety is evaluated, a safe dosage range is determined, and side effects are determined. In Phase II, the number of participants is increased to 100-300, and safety and effectiveness are further evaluated. Phase III increases the amount of people tested to between 1000 and 3000. Safety, effectiveness and side effects are again monitored with special emphasis on safety. Phase IV occurs after the drug or treatment has been marketed. Information about their effect in various populations is evaluated as well as any side effects associated with long-term use.

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