clinical trial a research study of how a new drug or treatment works on a disease or helps patients; also known as a clinical study
control group the group of patients receiving placebo (an inactive substance that looks like the experimental treatment) or standard care for a disease rather than the experimental treatment
informed consent the ongoing dialogue between researchers and participants that addresses patient concerns and questions and ensures patient protection throughout the trial
informed consent document a document that describes the rights of study participants; this document states all the facts about the trial, such as its purpose, duration, required procedures, potential risks and benefits, alternative therapies, and key contacts
Institutional Review Board (IRB) an independent group that oversees the actions and documents related to the clinical trial process; made up of medical specialists, nurses, social workers, medical ethicists, and patient advocates
peer review review of a clinical trial by experts chosen by the study sponsor; these groups review the trials for scientific merit, patient safety, and ethical considerations
phase a specific part of the clinical trial process, progressing from Phase I to IV, during which dosing, benefits, and side effects of a drug or treatment are studied
randomized a term meaning that patients are assigned different treatments or regimens based on chance