The Clinical Trials Process The Clinical Research Process Informed Consent
Each pharmaceutical company must go through the rigorous process of clinical trial research for every single medication developed from Tylenol to Viagra. Your involvement in clinical trials could help in the development of new medical treatments for diseases or prevention of disease complications. You, and many other people with similar conditions, may benefit from your willingness to participate.
Click on one of the links directly below to read a summary of the study, patient inclusion/exclusion criteria and compensation information specific to the study.
Should you decide to request additional information, just click on the link at the bottom of each summary and complete the online form. Completion of the online form does not obligate you to participate in any clinical research study. By completing the form, you are simply requesting that a nurse contact you by email, telephone or US mail.
Several additional clinical trial studies are under consideration at this time and are listed at left. Check this site often for an updated list.
(Click here to request additional information)
The Clinical Trials Process (top)
A Clinical Trial is a carefully designed study that is conducted with people who volunteer to receive investigational treatments under close supervision by specially trained medical research staff. All clinical trials are conducted with the approval of the U.S. government's Food and Drug Administration (FDA) and the oversight of a Centralized Institutional Review Board (IRB), whose obligation is to ensure that a participant's rights are protected, and that there is not exposure to any unnecessary risk.
Before a pharmaceutical company can initiate testing in humans, it must conduct extensive laboratory research, which involves years of experiments in animal and human cells. Most investigational medications have already been tested in humans for an average of 8 to 10 years prior to the phases of testing performed here.
The Clinical Research Process (top)
Clinical testing of experimental medications is normally done in three phases, each successive phase involving a larger number of people.
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PHASE I - Initial Safety Testing |
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PHASE II - Randomized Trials |
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PHASE III - Large Scale Testing |
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Informed Consent (top)
Informed Consent is a thorough review of the required study procedures, benefits and risks, and number of study visits over a designated period of time that is conducted prior to a decision as to whether or not to participate in a clinical research study at the initial clinic visit. Potential participants are given the informed consent form to read at their leisure in a quiet environment and are encouraged to ask questions following their review.
A copy of the consent form will be given to the participant to take home for reference.
As a volunteer in a clinical study, you have the right to withdraw from the study at any time and for any reason.
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