Mercy Cancer Services
Clinical Trials
What are clinical trials?
Clinical trials are studies, managed by government agencies, educational
institutions, private not-for-profit organizations, or commercial
businesses, to develop, produce, and evaluate the effectiveness of new
treatments and therapies for diseases.
What are types of clinical
trials?
According to the National Cancer Institute, there are different types of
cancer clinical trials, including:
-
prevention trials designed to keep
cancer from developing in people who have not previously had cancer.
-
prevention trials designed to prevent a new type of cancer from
developing in people who have had cancer.
-
early detection trials to find
cancer, especially in its early stages.
-
treatment trials to test new
therapies in people who have cancer.
-
quality of life studies to improve
comfort and quality of life for people who have cancer.
-
studies to
evaluate ways of modifying cancer-causing behaviors, such as tobacco
use.
What is a clinical trial
protocol?
Clinical trial protocols are the action plans or guidelines that must be
followed during the course of any study. Guidelines may cover: the
design of the study - what it will study and how who may participate -
criteria for patients who enter the study what medications and medical
tests will be used to follow the participants what information is being
searched for Several research centers may be involved in the study, and
each uses the same protocols to ensure that information from all centers
can be combined and compared.
Who can participate in a
trial?
Each protocol in a trial defines specific characteristics, called
eligibility criteria, that participants should have in order to
participate in the study. Characteristics may include type of disease
and its stage, as well as the participant's age and general health.
Eligibility criteria help assure that the study results answer the
research question and identify who will benefit in the future from the
approach being studied.
How are trial participants
protected?
There several procedures in place, as part of the protocols, to protect
the safety of the participants. Two groups that oversee the safety
procedures are the: organization that sponsors the study, for example,
the National Cancer Institute
Institutional Review Board (IRB)
that oversees clinical research in the healthcare institution. The IRB
includes physicians, other healthcare providers, consumers, and
sometimes members of the clergy, who do not have any personal interest
in the results of the study. As neutral reviewers, they ensure that the
study is conducted fairly and that there is not a high probability of
harm to the participants.
Phase III trials also have a
special group called a Data Safety and Monitoring Committee that looks
at the test results, monitors the safety of the participants, and
decides whether the study should go forward as originally planned.
For information on how to
participate in a clinical trial, please contact Sherry Landreth, RN,
BSN, OCN. She can be reached through the Cancer Resource
Center at (405-752-3388).
For additional information about
clinical trials
visit Mercy's health information library.
Read more about clinical
trials at Mercy.
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