Clinical Trials (cont.)

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How is a clinical trial performed, and what sort of preparation is needed?

Before a clinical trial can be carried out, thorough preparation is necessary, including extensive reviews of the proposed trial, its methodology, and the goals of the trial. An Institutional Review Board (IRB) consisting of physicians, statisticians, researchers, patient advocates, and others must pre-approve every clinical trial in the U.S. The job of the IRB is to ensure that the trial is ethical, legal, and that the rights of those participating are fully protected. For example, individual participants' names are kept secret and not included in the results or publicly available information about a trial.

Every clinical trial has a strictly defined protocol that is approved by the IRB. A protocol describes what types of people may participate in the trial; outlines the exact the schedule of tests, procedures, medications, and/or dosages involved in the trial; and specifies the length of the study. Generally, doctors check the patient thoroughly at the start of the trial, provide instructions and directions for participation in the trial, monitor the patient during the actual trial, and remain in contact, sometimes with further monitoring after the trial is completed.

In many clinical trials, patients will be randomly assigned to a test group or a control group. The control group receives the standard and accepted treatment for a given condition, while the test group receives the experimental medication or treatment to be evaluated. When a trial is "double-blinded," neither the participants nor the treating doctors know if an individual patient is receiving the standard treatment versus the experimental treatment. Double-blinded trials offer the advantage of allowing the treating health-care team and the patient to make unbiased observations about patient progress and the effectiveness of the treatment being evaluated. A double-blind study is also referred to as a double-masked study. Results obtained from a randomized, double blind clinical trial are considered the most accurate and reliable types of results, and help those conducting the trial to draw the most accurate conclusions.

Medically Reviewed by a Doctor on 2/26/2014

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