Volunteering to participate in a clinical study is one of the best ways you can contribute to the understanding of the diseases that affect people and the development of new therapies. Volunteers are important to the clinical study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications for a broad range of health problems.

 

 

The U.S. Food and Drug Administration (FDA) typically must authorize a drug company's proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in human subjects.

 

 

Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows volunteers to ask questions freely with the clinical investigator.

 

 

 

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A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug's ability to treat a condition, its safety and its possible side effects.

 

 

People with the condition being studied as well as healthy people can volunteer to participate in a study. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the conidtion being studied.