If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. Clinical trials sometimes study the role of caregivers or support groups.īefore the U.S.
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A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Still others test ways to prevent a health problem. Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Read and share this infographic (PDF, 317K) to learn why researchers do different kinds of clinical studies.Ĭlinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. These studies may help identify new possibilities for clinical trials. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. Observational studies observe people in normal settings. There are two types, observational studies and clinical trials.
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