What is a Clinical Trial?
A clinical trial is a careful process to test a new procedure, drug, or device to prevent, screen for, treat, or improve quality of life surrounding a disease. The disease may be food allergies, asthma, arthritis, cancer, Alzheimer’s disease, diabetes, or many others. Clinical trials touch nearly every person’s life in some way.
Clinical trials test potential treatments in human volunteers to see whether the treatment should be approved for wider use among all people. Clinical trials benefit medical knowledge and contribute to better public health. The U.S. Food and Drug Administration (FDA) requires potential therapies be tested extensively before approved for all patients.
Clinical trials are sometimes described by phase. Potential treatments are first studied in laboratory animals and other ways before tried in people. Treatments with acceptable safety results and which show the most promise move into clinical trials. There are four phases to a clinical trial with each phase answering a different research question. Each phase also grows the trial to a larger number of people.
Clinical trials test “new” treatment, but whether the treatment offers better benefit to patients is not known until the clinical trial is complete. Clinical trials are an integral part of new medical discoveries.
Clinical trials take place in many locations, from hospitals or universities to doctors’ offices and community clinics. Every clinical trial is led by a principal investigator, often a medical doctor, with a dedicated research team.
The FDA strives to protect clinical trial participants and to provide reliable information to interested participants. Effort is made to control risk to clinical trial participants but some risk is unavoidable as it is a test of a new medical treatment. A clinical trial must be as safe as possible and must be voluntary. Every clinical trial participant must provide informed consent and can quit a trial anytime.
Many studies end early or never begin because there are not enough volunteers. The price to all of us comes in the form of higher costs for public health and longer time waits to achieve health care breakthroughs.
Both healthy and ill persons may apply for clinical trial participation. There is a great need for female, African American, Asian American, and Hispanic clinical trial participants. For example, African Americans are most disproportionately affected by cancer, cardiovascular disease, stroke and diabetes, but African Americans do not represent that proportion of the population in clinical trials.
Clinical trial participation is not about one condition, one institution, or one study. Clinical trials touch nearly every person’s life in some way.
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