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Clinical trials Should you participate? By Harold Kaiser, MD
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any of you may have seen an advertisement for a Clinical Trial, or Clinical Research Study, in the newspaper, on TV, or on social media and may be considering volunteering to participate. Before you start, there are several important points to consider.
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What are they? Clinical trials are research studies that are a necessary part of the process a drug or medical device goes through before approval. This article explains the process of determining if a new medication is effective and safe. The need for clinical trials is large because more than half the U.S. population takes some kind of prescription medication. More than 90 percent of the population reports taking over-the-counter medication on a regular basis. The medications that people use require extensive and expensive research, development, and clinical testing. By the time a drug is approved by the federal Food and Drug Administration (FDA), approximately $1.2 billion has been invested in it (this includes the cost of compounds that fail to be approved). The approval process may take up to 15 years and only about one of 10,000 drugs gets approved. A new medication usually begins in the laboratory. After being tested in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials. Drugs are tested to establish that they are safe and effective. Process Clinical trials are organized into four phases. Phase I Researchers test an experimental drug in 20–80 healthy volunteers to evaluate its safety, to determine a safe dosage range, and to identify side effects. Phase II The experimental drug is tested in 100–300 people who actually have the condition the drug is designed to treat. This phase is to determine safety and effectiveness. Phase III
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Researchers test the experimental drug in large groups of people (1,000–3,000) to confirm effectiveness, monitor side effects,