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Basics of Clinical Research
Basics of Clinical Research | Current Studies | Glossary | Register Online Now

What are Clinical Trials?  Clinical Trials are research studies designed to answer specific questions about medicines, devices, vaccines, or new ways of using known treatments. They are conducted at hospitals, universities, and doctor's offices and are the fastest and safest way to prove which treatments work best in patients.

Why is it important? Clinical trials are essential to the development of new and potentially life-saving mediations and treatments. Before a medication is approved for use in the U.S. by the Food and Drug Administration (FDA), it must undergo three phases of clinical trials to assure its safety and efficacy. Most importantly, study participants are essential to the development and release of medications and treatments which are likely to improve the quality of life for millions of people across the country and around the world.

What are the risks/benefits to participating? Participating in a clinical trial is a great way to play an active role in your own healthcare. You will receive education about the latest medical management for your condition and may have access to medications and treatments years before they become accessible to the public.

In the trials that have a placebo group, you will be informed if there is a possibility you will receive placebo medication. Placebo is an inactive pill, liquid, or powder that has no treatment effect. It is often called a "sugar pill" by researchers and it is used in comparison to the treatment being tested to determine the treatment's efficacy. Not every clinical trial uses placebos; some provide every participant with an active medication.  Also, if at any time during a clinical trial you feel your condition is worse, you are free to withdraw from the study.

The same ethical and legal codes that govern medical practice also apply to clinical trials. Participants are protected by federal regulations and every clinical trial must be approved and monitored by an independent Institutional Review Board to ensure that the risks are as low as possible.

Are there costs? Study participants receive expert medical care, including blood tests, EKGs, x-rays, and more, at no cost during the course of a study.

Is there compensation?  At West Coast Clinical Trials, we understand your time is valuable so we provide study participants with monetary compensation for their time and travel

How long do studies last?  Each study is for a specific amount of time and the time varies by the drug that is being tested.  There are four phases  in the life of the drug before the drug is released to the public. 

Phase I:
A small group (few dozen) of normal, healthy volunteers try a new drug or treatment for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II:
A larger group (few hundred) of volunteers that have a particular disease or condition try the new drug to determine its effectiveness and to further evaluate safety and side effects.

Phase III:
This is usually the final phase of testing before a drug is approved by the FDA. Hundreds to thousands of participants help in providing the efficacy, risks, and side effect information that is used to determine how physicians will prescribe the drug once it is approved.

Phase IV:
Occasionally studies are done after a drug has been released to the public in order to gather additional information to determine a drug's optimal usage or to compare it to other existing therapies.

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