Should I Volunteer?
Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of 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.
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Participating in the research process that may lead to new therapies
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Receiving medical care from physicians during the study
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Learning new information about your condition
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Possibly meeting people with similar conditions
What is a Clinical Study?
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 side effects.
How is a Drug Approved for Testing?
The U.S. Food and Drug Administration (FDA) must authorize a new drug for use in clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans. Detailed information about this process from the FDA is available through the following link: http://www.fda.gov/fdac/special/newdrug/ndd_toc.html
Who can be in a Clinical Study?
People with the condition being studied as well as healthy people can volunteer to participate in different studies. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the condition being studied.
Each study has specific requirements such as age, sex or medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician prior to participating in the study. In addition to the known risks there may be unknown risks such as medication side effects involved in participating in a clinical study. Study procedures, risks and benefits are explained to volunteers during the Informed Consent process.
What is Informed Consent?
Informed Consent is the process designed to give volunteers the information that they need to decide about volunteering to participate in a clinical study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research study.
Who is the Institutional Review Board (IRB)?
The IRB is a group of health care professionals and members of the local community, which must review and approve a clinical study before it begins. The IRB's primary responsibility is to protect the safety and rights of study participants.
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