Here are some common questions and answers about clinical research studies.
A clinical research study tests a drug to see how well it works and how safe it is to use. Clinical research studies, also known as clinical trials, must be done before drugs can be approved to be used by patients.
By volunteering, people help doctors find new and improved drugs and better ways to provide care. As a study goes on, the doctor and researchers gather more information about the study drug. Results may show that the study drug improves patient outcomes, offers no benefit, or causes patients unexpected harm. All these results are important because they advance medical knowledge and help improve patient care.
If regulatory agencies review the study results and feel that the study drug is safe and effective, they may approve it for use by the public.
Clinical research studies are regulated, following rules set by health authorities. The research study will follow a protocol, which is a detailed study plan explaining what researchers will do in the study.
Each research study must also be approved by an institutional review board (IRB). IRBs are groups of people who help protect the rights and welfare of people participating in research studies. They are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people.
Your privacy will also be protected. The research team can’t tell anyone that you’re participating in a research study without your permission. All the information collected during the study will be kept confidential, and your name won’t be listed in any reports based on the study.
After a clinical research study is finished, all the information is collected and analyzed to help determine the drug’s safety, effectiveness, and side effects.
Please talk to your doctor or healthcare provider to learn about your treatment options after you complete a study.
Yes, you have the right to leave a research study at any time. When you want to leave, tell the doctor or research team. It would be helpful if you explain your reasons for leaving, although you don’t have to.