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What is a Clinical Trial?


A clinical trial is a research study in human volunteers that is carefully designed to answer specific health questions. Clinical trials are conducted for cancer patients to identify whether the latest approaches to managing side effects, quality of life, cancer prevention, diagnosis, and treatment are safe and effective.


People who meet specific eligibility criteria and choose to participate in a clinical trial:


    * Are partners in the research process

    * Receive close medical supervision during the study

    * Provide researchers with valuable feedback on their experiences


The FDA, Institutional Review Boards (IRBs), ethics committees (ECs), and other regulatory authorities carefully review all clinical trials and make sure participants’ rights are fully protected and that they are not exposed to any unnecessary risks. Carefully conducted clinical trials sponsored by government agencies or private companies are considered the standard way to find treatments that work. All drugs must go through the following three phases of clinical research before your doctor can prescribe them:


    * Phase I – Focuses on safety in a small number of volunteers

    * Phase II – Tests the effectiveness of the drug on a small number of volunteers

    * Phase III – Usually tests the drug on a large number of volunteers in comparison with the current standard therapy

   


Clinical trials may not be right for everyone, but they are one important option to understand and consider. Participation in a clinical trial is a personal decision that should be made in consultation with your doctor.