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Booth Gardner Parkinson's Care Center

Research

Our Parkinson’s medical and rehabilitation team has ongoing research for people living with Parkinson’s disease. Our research focuses on how our care impacts the quality of life of our patients as well as providing access to current clinical research drug studies.

Our research team includes both medical and rehabilitation specialists in movement disorders. Our current and active research studies can be found under our Active Research Studies link. 
  
The following definitions will help you understand more about the various stages of research and steps that a drug must go through before it is approved for use by the FDA.

Clinical Trial
A clinical trial is a research study designed to test the safety and/or effectiveness of drugs, devices or treatments in humans.

Clinical trials can usually be divided into four categories or "phases.” The term "phase" refers to one of the four stages of testing that a drug must undergo before it can be approved by the Food and Drug Administration (FDA) for marketing. The four phases must be completed in order, and positive results must be obtained before moving to the next phase.

Phase I
The first of four stages of clinical trials in humans. In Phase I studies, the experimental drug is usually given to a small group (20-80) of healthy volunteers. The purpose of a phase I study is to gather information on safety.

Phase II
A Phase II trial involves a larger number of participants (100-300) who usually have the disease for which the experimental drug is being tested. The purpose of this phase is to gather additional information on safety and effectiveness. Often these studies are “blinded” – neither the patients nor the researchers know who is getting the study drug. About one-third of experimental drugs successfully complete both phase 1 and phase 2 studies.

Phase III
The third stage of testing involves large numbers of patients (1000-3000) who have the disease for which the experimental drug is being tested. This stage of testing usually compares the experimental drug to the current approved treatment for the disease. An application to approve the experimental drug can be submitted after this stage of testing.

Phase IV
This stage is performed after the drug has been approved by the Food and Drug Administration (FDA). In this stage, studies are done to compare the drug to a competitor, examine the long-term effects of the drug, or to look at the drug in new types of patients. 

 
What is a Placebo? An inactive pill, liquid or powder (or sham surgery) designed to resemble the treatment being tested. It is used as a control to measure any psychological effects testing may present. Most studies compare placebo with the treatment drug to assess its effectiveness.


 

 


This page can be found at:
http://www.evergreenhealthcare.org/neurosciences/parkinson/research.htm