Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study. This booklet provides detailed information for a patient considering participating in a clinical trial. Clinical Trial A carefully designed investigation of the effects of drug, medical treatment, or device on a group of patients. Clinical Investigator A medical researcher in charge of carrying out a clinical trial's protocol.
Researchers are usually doctors, nurses, pharmacists or other health care professionals.
Coordinator This individual manages the conduct of the clinical trial. A government agency that enforces laws on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public. A discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial.