What is a clinical trial?
A clinical trial is a research study performed to answer specific
questions about new therapies or new combinations of therapies.
Information learned from a clinical trial helps improve health
care and treatment. Each trial follows a protocol (a written
detailed plan) that explains why there is a need for the study,
what it is intended to do and how it will be conducted. Carefully
conducted clinical trials are the quickest and safest way to find
treatments for specific illnesses.
Who can participate in a clinical trial?
Each trial has specific criteria (eligibility criteria or rules)
that must be satisfied. Examples of eligibility criteria are age,
type of disease, severity of disease, and a participant's history
prior to any study treatment. Participants must have a similar
degree of illness, so there is a likelihood they will respond to
treatment in similar ways
What is an Informed Consent Form (ICF)?
This document describes the rights of study participants and includes
details about the study, such as its purpose, duration, required
procedures and key contacts. Risks and potential benefits are explained.
After reading this document carefully, the participant will decide whether
or not to sign it. An informed consent form is not a contract and the
participant can withdraw from the trial at any time. Informed consent
is an ongoing process throughout the study.
For more information, call the McGivney Center (203) 789-3545 or
e-mail Pat Garofolo, M.S., B.S.N.,
study coordinator.
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