Clinical Research Studies
Clinical trials are conducted for many reasons:
- to determine whether a new drug or device is safe and effective for people to use.
- to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
- to learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.
Regulations and policies have been developed to help protect the rights, safety, and well-being of people who take part in clinical research studies and to help ensure that these studies are conducted according to strict scientific and ethical principles. Before a clinical research study can begin, an institutional review board (IRB) or ethics committee (EC) must review and approve the study.
Before joining a clinical trial you will be given an informed consent document that describes your rights as a participant, as well as details about the study. Signing it indicates that you understand that the trial is research and that you may withdraw from the study at any time for any reason. The informed consent is part of the process that makes sure you understand the known risks associated with the study. The study team will inform you of the potential risks and benefits of study participation and answer any questions.