Clinical Trials: Availability, Volunteers, Drug Research

Author: Disabled World - Contact Details
Updated/Revised Date: 2022/04/13
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Synopsis: Information and availability of federally and privately supported clinical trials conducted in the United States and around the world. Clinical trials are defined as research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

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Clinical trials are defined as research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison.

Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

During the clinical trial, the investigators: recruit patients with the predetermined characteristics, administer the treatment(s), and collect data on the patients' health for a defined period. These data include measurements like vital signs, amount of study drug in the blood, and whether the patient's health gets better or not. The researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests.

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The U.S. National Institutes of Health (NIH) organizes trials into five different types:

Clinical trials used in drug development are sometimes described by phase. In the U.S. these phases are defined by the Food and Drug Administration (FDA). Clinical trials involving new drugs are commonly classified into four phases:

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Cite This Page (APA): Disabled World. (2022, April 13). Clinical Trials: Availability, Volunteers, Drug Research. Disabled World. Retrieved November 30, 2023 from www.disabled-world.com/medical/clinical-trials/

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