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What is A Clinical Trial?

Clinical trials are tests that are used to help determine the effectiveness and safety of medical treatments. These medical treatments might be drugs, diagnostic equipment and procedures, medical devices and other therapies.

Some studies are “interventional”, which means that the research subjects (the people who take the test) are given a treatment or some other kind of “intervention”, and their outcomes are measured or compared with some other group that receives no intervention. “Observational” studies are those where the research subjects are simply observed and their outcomes measured.

Often, clinical trials compare new treatments with older, more established treatments. The goal is to discover whether the new treatments are more effective than the older treatments. It is important to know that these trials are only conducted after a certain safety level of the treatment has been established.

Clinical Trials are sponsored by governmental organizations, pharmaceutical companies, biotechnology companies, or other medical organizations, but usually these companies ask other companies, called “Contract Research Organizations” (or CROs) to actually manage the trials.

The CROs will work with reputable medical institutions, such as GW Research, to conduct the actual testing that they specify. The testing that these medical institutions conduct must follow a strict set of guidelines and procedures when testing the new treatments. All aspects of the trial are reviewed and approved by an Institutional Review Board (IRB) and they are all under the guidelines and supervision of the Food and Drug Administration (FDA).

Guidelines and Supervision

These guidelines are in effect in order to protect the safety of the individuals who participate in the study, to ensure that the tests are run consistently, and that the results of the trials are accurate. The safety and respect for the individual rights of the pariticipating subject, along with the maintenance of complete privacy and anonymity are essential.

When you participate in a clinical trial, you are helping to discover new treatments to manage, relieve, or cure the condition that the trial is targeting. Your participation in clinical trials may be important to the success of a particular treatment. Your participation is completely voluntary, and if at any time you prefer not to continue or participate, you may leave without any consequences. We will make the best efforts to help you with your condition once not enrolled in a study.

For more information on Clinical Trails and how they work you can visit http://clinicaltrials.gov/ct2/info/understand

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