Sierra Clinical Research
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A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Most clinical trials that involve the testing of a new drug follow a series of steps, called phases. This process allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of four phases:
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Although the requirements for release of some patient information are defined by law, Sierra Clinical Research has a regulated policy which states data is never released without the express, specific, written consent of the patient. All data collected for Clinical Trials is confidential and is not shared with insurance companies or mailing lists. It is only the data collected for the trial itself, (blood pressures, lab results, vitals etc., NO personal information) that is reviewed by the Pharmaceutical Company, FDA and or Ethics Committee.
What is a Clinical Trial?