What is a clinical study?
A clinical study evaluates investigational medical interventions, including investigational drugs. Clinical studies determine the safety and/or efficacy of an investigational drug.
How are studies monitored?
Before a clinical study can start in the United States, the sponsor of the proposed study 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 study, and determine whether the study 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 study to ensure the participants’ safety.
What is informed consent?
Informed consent is the process of educating prospective study participants on the study protocol, its risks, and its potential benefits. All study 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 study. It exists to make sure patients know what they are signing up for, if they take part in a study.
For more information visit https://www.fda.gov/ForPatients/ClinicalTrials/default.htm