What are clinical trials?
• A research study involving human volunteers to answer specific health questions.
• Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.
• Clinical trials are conducted according to a plan called a protocol.
• A protocol describes what types of patients may enter the study; schedules of tests and procedures, drugs, dosages, and length of study, as well as outcomes that will be measured.
• Each person participating in the study must agree to follow the protocol.
Why are clinical trials conducted?
• To see if a new drug or device is safe and effective for people to use.
• To compare existing treatments to determine which is better.
• To study different ways to use standard (approved) treatments, so they will be more effective, easier to use, and/or decrease side effects.
• To learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.
What are some of the possible benefits of my participation?
• Gain access to potentially new research treatments.
• Receive expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
• Help others by contributing to medical research and treatment advances.
What are some of the possible risks of my participation?
• There may be unpleasant, serious, or even life threatening side effects resulting from the treatment.
• The treatment may not be effective.
• Participation in the trial may be demanding and time consuming.
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