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Clinical Trials
What are clinical trials?
Clinical trials
are studies conducted in order to develop, produce, and evaluate the
effectiveness of new treatments and therapies for diseases. All clinical trials
involve the participation of human subjects or the use of data collected from
medical records. The MetroHealth System manages approximately 700 clinical
trials ranging in focus from vaccination in children to new devices used to save
the lives of traumatic injury patients.
What are the phases of a
clinical drug trial?
MetroHealth offers many clinical
trials that you can volunteer to participate in. A clinical trial is
just one of many treatment options available for you here at The
MetroHealth System.
If you are a person interested in
volunteering for a Clinical Trial,
click here
If you are a sponsor interested in The
MetroHealth System being a study site,
click here
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Most clinical drug research progresses in an orderly series of steps or
phases.
- Phase I trials are studies to evaluate how a new drug should be
given, and how safe it is to humans.
- Phase II trials provide
preliminary information about how well the new drug works, and generates more
information about its safety and benefits.
- Phase III trials compare a promising new drug, combination of
drugs, or procedure with a current standard of treatment.
- Phase IV trials include the continuing evaluation that takes place
after FDA approval, when the drug is already on the market and available for
general use.
How are clinical research trial participants/volunteers protected?
There are several procedures in place, as part of the protocols, to protect
the safety of the people who participate. Two groups that oversee the safety
procedures are:
- The organization sponsoring a trial also monitors the safety of
volunteers. Depending on the type of sponsor, there may be a monitoring board
or a monitor that reviews all study records.
- The MetroHealth System's Institutional Review Board (IRB). The IRB includes
physicians, other health care providers, consumers, and community members who
do not have any personal interest in the results of the trial. As neutral
reviewers, they try to ensure that the trial is conducted fairly and that
participants are not likely to be harmed. All clinical trials require approval
from the IRB before the trial may begin. The IRB reviews clinical trials on no
less than an annual basis and conducts thorough, random audits to insure that
patient's rights are being protected.
Who pays the costs of the research procedures?
Even if you have health insurance, your coverage may not include some or all
of the costs associated with a clinical trial. The sponsor of the clinical trial
usually covers the costs of the study medication and any tests that are
necessary due to the trial. When your doctor or nurse reviews the study with
you, he or she will provide information regarding costs associated
with the clinical trial.
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