WHAT IS A CLINICAL TRIAL?
A clinical trial evaluates investigational medical interventions, including investigational drugs. Clinical trials determine the safety and/or efficacy of an investigational drug.
HOW ARE TRIALS MONITORED?
Before a clinical trial can start in the United States, the sponsor of the proposed trial must file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA). Both the FDA, as well as an independent Institutional Review Board (or IRB), which provides ethical and regulatory oversight of research in human participants, will review information about the investigational drug as well as the protocol (study plan) for the proposed trial, and determine whether the trial can begin.
WHAT IS AN INSTITUTIONAL REVIEW BOARD?
An Institutional Review Board, or IRB, reviews all research at a site to protect the rights and safety of trial participants. They review the research before and during the trial to ensure the participants’ safety.
WHAT IS INFORMED CONSENT?
Informed consent is the process of educating prospective trial participants on the trial protocol, its risks, and its potential benefits. All trial participants will be provided an informed consent document with all necessary information. To be eligible to participate, a patient must sign this document confirming they understand the expectations, risks, and rewards of the trial. It exists to make sure patients know what they are signing up for, if they take part in a trial.
For more information visit https://www.fda.gov/default.htm