A clinical trial is a research study to answer specific questions about vaccines or 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. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.
Questions relevant to the trial should always be addressed to the trial doctor for the duration of your trial participation. Any clinical trial participation is always voluntary. In most clinical trials the treatment, office visits, and all tests are free. You may also be given financial compensation for participating in some cases. Your doctor or the study coordinator at your doctor's office should share information regarding the compensation package with you during your first visit.
Are Clinical Trials safe?
Clinical trials are conducted in a healthcare setting (a hospital or clinic) and are typically monitored by a trained healthcare professional. An Institutional Review Board or IRB approves all clinical trials. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group is held responsible for agreeing that a trial does not represent an unreasonable risk to patients who are participating.
Trials are also reviewed by the FDA. Your doctor is responsible for your well being and is the best person to decide whether or not you are eligible to participate in a trial. Whenever you agree to enter a trial you are given the name and telephone number of a contact in your local physician's office who will answer yourquestions as well as a member of the IRB whom you can contact if you have any doubts.
How will I Know if I am Eligible for a Clinical Trial?
Each trial has certain requirements for participation. Your doctor will take a medical history from you and may request additional testing to determine if you are eligible according to the criteria for the study.
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