The Different Phases Of Clinical Trials
Clinical trials are scientific studies that are conducted to find ways to prevent, screen for, diagnose and treat diseases. These trials help scientists discover which approaches work best for certain illnesses or groups of people. There are four phases of clinical trials.
Phase I determines if a new treatment is safe and the best way to administer the new treatment, as well as assessing whether the treatment has any side effects. This trial is usually conducted with 15 to 30 patients divided into small groups called cohorts.
Phase II assesses the safety and efficacy of an experimental treatment. Less than 100 patients usually join a Phase II trial.
Phase III attempts to discover if a new treatment is better than a standard treatment. This phase may include hundreds to thousands of patients. Each patient is divided into two groups: Control group – the group that gets the standard treatment Study group – the group that gets the new treatment being tested
Phase IV finds additional information about the long-term benefits and side effects of the treatment. Doctors study the treatment that has already been approved by the FDA. The goal of this phase is to continue studying the side effects of a new treatment.
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