A clinical trial is a research study that tests how new medications,
detection or diagnostic tools, or devices work in human subjects. It
consists of four phases.
Phase I studies assess safety.
Phase II studies focus on efficacy and evaluate how the
investigational product affects the human body.
Phase III studies enroll a large number of participants and
compare new therapies to current ones. They only begin after
promising results are achieved in Phase I and II trials.
Phase IV studies occur after a treatment has been approved. They
often compare that treatment with others on the market or may
monitor long-term effectiveness.
Why participate in a clinical trial?
When you participate in a clinical trial, you may:
Gain access to potential new treatments for a disease or
Take advantage of a unique healthcare choice
Advance medical knowledge
Help others who may develop or have a similar disease or
Who can participate in a clinical trial?
Every clinical trial has specific guidelines regarding who can
participate. The established criteria will either include or exclude an
individual from a study. These criteria are based on factors such as
age, gender, type and stage of a disease, previous treatment history and
other medical conditions. Individuals must qualify for the study before
they can participate in the trial. It is important to note that
inclusion and exclusion criteria are not used to reject people
personally. They are used to identify appropriate participants and keep
them safe and to help ensure that researchers will be able to answer the
questions they plan to study.
For more information, call 1.866.CALL.MLH.