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Clinical Research

by dasamw01 last modified May 13, 2009 08:44 AM

What is a clinical trial?
Studies test new drugs/therapies for safety, effectiveness, and best dosing regimen for a particular drug on volunteers. The FDA requires this investigation to obtain approval for marketing, However, all have been thoroughly evaluated and tested on animals and healthy volunteers.

Why should I volunteer for a clinical trial?
Grants an opportunity to receive newest state-of-the-art treatment, high quality care, potential for coomplimentary procedures, medications and labs, and to aid in the discovery of new or enhanced treatments for life-threatening/chronic diseases.

Who can participate?
Each trial has qualifying criteria, (i.e., disease, age, health limitations). Individuals who meet study criteria may be considered as a study participant. 

Will I always get the new drug?
Not necessarily. Many trials are designed to use placebos ("sugar pills") that are packaged the same as the real medicine. Neither the patient, the doctor, or the research staff knows if the volunteer is receiving the experimental drug.  

Are studies safe?
The FDA (Food and Drug Administration) reviews and approves studies involving new drugs based upon federal government regulations to protect volunteers. Additionally, the IRB, (Institutional Review Board)  monitors all studies at the University. These agencies ensure studies are conducted in a legal and ethical fashion. Your study physician is directly responsible for your safety and works closely with a research coordinator  to review all test results.

How will I know what is expected of me if I volunteer?
Study participants must sign an informed consent which provides  information regarding potential risks/benefits of participation, number of visits, what will be done at each visit, rights as a volunteer, and alternatives to participating in the research study.

What if I change my mind?
You may choose not to volunteer, or you may change your mind and leave a research study at any time. Your health care and other benefits will not be affected by your decisions.

 How do I know what studies are available?

COMING SOON! 

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