Why are clinical research studies conducted?
Clinical research studies, or trials, are conducted to test investigational medications for treatment of diseases and conditions. Studies help determine if investigational medications are safe to use and work to improve people's health. Before any medication can be approved and made available to the public, it must go through several phases of clinical research. This study is in Phase Two.
Why do people participate in clinical research studies?
People participate in clinical research studies for a variety of reasons. Some may participate because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease to potentially help them and others in the future.
Are clinical research studies safe?
Clinical research studies follow a specific set of standards and are closely regulated to help ensure the safety of all participants. Safety precautions are put into place to protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is reviewed by an Institutional Review Board, which is a group of people responsible for protecting the safety and rights of research subjects. Before you provide consent to participate in any clinical research study, you will review potential risks and benefits, and the study staff will answer any questions you may have.
What if I have questions during the study?
You may ask questions of the study team at any time before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
Can I leave the study once it has started?
Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason. Study protocols are designed to include an adequate number of participants to allow researchers to properly analyze the results when most participants complete the study. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you must leave the study early, the study doctor may ask that you return to the study site for a final follow-up visit to ensure your health and safety, but there will be no negative impact on the care you receive.
Can I see my regular doctor, or other doctors, during the study?
You can visit any doctor to meet your health needs during the study. You should let your study doctor know if you plan to see another doctor during the course of the clinical research study, and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical trial. It is important to note however that you should not be participating in additional clinical trials of investigational drugs while participating in the A083-03 study.
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