WHAT IS A CLINICAL RESEARCH STUDY?
A clinical research study (or clinical trial) tests the safety, effectiveness and the side effects of an investigational drug or device on a group of volunteers. All clinical studies are conducted in accordance with federal regulations and ethics committee guidelines. These ethics committees review the clinical study protocol to help ensure patient safety and confidentiality.
Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new investigational treatments.
After clinical study participation has ended, the study doctor may discuss future treatments with volunteers. All of the information that is collected during the study will be analyzed to learn more about the safety and effectiveness of the research drug. |
