A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Phase I - tests a new drug or treatment in a small group
Phase II - expands the study to a larger group of people
Phase III - expands the study to an even larger group of people
Phase IV - takes place after the drug or treatment has been licensed and marketed.
The value of medical research and subsequent clinical trials can't be under estimated. The results of clinical trials not only increase our understanding of various diseases, but allow us to find better and more effective treatments with fewer side effects and ultimately help find ways to prevent various diseases altogether.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to variousgovernment agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
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