A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety, and its possible side effects.
People with the condition being studied may be eligible. The FDA has very strict criteria that each volunteer must meet to gain entry. Each study has specific requirements such as age, sex, or medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Study procedures, risks, and benefits are explained to volunteers during the informed consent process.
The U.S. Food and Drug Administration (FDA) typically must authorize a pharmaceutical company’s proposal to conduct clinical studies. Pharmaceutical companies must do years of laboratory research before they can begin testing medicines in humans. An Institutional Review Board or IRB for short is an independent group of healthcare professionals and members of the local community, which must review and approve a clinical study before it begins. The IRB carefully reviews study activities, because its primary responsibility is to protect the safety and rights of study participants.
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