In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products such as drugs, devices, and procedures. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention.
Clinical research is credited to the development of new drugs, new surgical procedures and devices that are designed to advance the public’s health. Clinical research has also assisted doctors in discovering new ways to identify people at risk of certain diseases and could benefit from new treatments. Medical advances have occurred because people volunteered to participate in clinical trials and other types of clinical research.
Clinical trials are performed in the following phases:
- Phase I: Tests a new therapy for the first time in a small group of people to determine if it is safe, find the right dose, and learn about side effects.
- Phase II: Involves more people to determine how well the new therapy treats a disease and whether the treatment is safe.
- Phase III: Broadens the study to include large groups of people to determine if the new therapy works well, if it has side effects, and how it compares to other therapies.
- Phase IV: Once the treatment is approved by the U.S. Food and Drug Administration (FDA), these studies evaluate the effects of new drugs and treatments over a long period of time in large groups.
Benefits of Physicians participating in clinical trials:
- Help people who are sick
- Assist in discovery of safer or better treatments
- Discover ways to improve medical care
- Learn how the human body and mind work
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