| What is a pharmaceutical research study? | ||
A pharmaceutical research study is a scientific evaluation of an investigational product conducted to determine if it is a safe and effective treatment option. Pharmaceutical and biotechnical companies spend years analyzing investigational compounds in the laboratory. Once the pharmaceutical research company identifies a compound that they feel will be an effective medication, a protocol is devised to test the product. The U.S. Food and Drug Administration and Institutional Review Boards review protocols to determine if they are safe and ethical, prior to any testing on humans. There are four phases (phases are listed below) of clinical trials, ranging from testing the compound on a small number of healthy adult volunteers to studies that encompass thousands of patients and involve a comparison of the investigational drug to placebo (inactive substance) and other, approved, treatment options. If the data collected during the research studies proves the drug to be a safe and effective treatment option, the FDA then approves it as a new prescription medication. WHAT ARE THE PHASES OF CLINICAL TRIALS? Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: In Phase I trails, researcher’s test a new drug or treatment in a small group of people (20-80) for the first time to evaluate ifs safety, determine a safe dosage range, and identify side effects. In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use. |
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