 About
Clinical Trials
A clinical trial is ...
A clinical trial is a research study in human volunteers
that is carefully designed and monitored to answer
specific questions about investigational drugs or devices. A
properly conducted and controlled research study will
determine safety and effectiveness of the drug, device,
or treatment modality under investigation. Carefully
conducted clinical trials are the fastest and safest
way to find treatments that work in people to improve
health. Interventional trials determine whether experimental
treatments or new ways of using known therapies are
safe and effective under controlled environments.
Patients benefit from ...
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Access to cutting edge technologies
that are otherwise not available.
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Increased patient monitoring
by healthcare provider.
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Additional tests and study-related
medical care (study-related care is generally free).
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An opportunity to be part of
new medical discoveries.
Clinical trials are available
to qualified volunteers.
Clinical research is an extension of the
services provided by Holy Cross Hospital to the community
of South Florida. The clinical trials conducted
through HCRC are available to anyone who meets
the required medical criteria.
All clinical trials have guidelines about
who can participate, called inclusion/exclusion
criteria.
Using inclusion/exclusion criteria is an important
principle of medical research that helps to produce
reliable results. The factors that allow someone to
participate in a clinical trial are the "inclusion
criteria" and those that disallow someone from
participating are the "exclusion criteria".
These criteria are based on such factors as age, gender,
the type and stage of a disease, previous treatment
history, and other medical conditions. Before deciding
to enroll in a clinical trial, a participant must qualify
for the study.
Some research studies seek participants with illnesses
or conditions to be studied in the clinical trial,
while others need healthy participants. It is important
to note that inclusion and exclusion criteria are not
used to reject people personally. Instead, the criteria
are used to identify appropriate participants and to
keep them safe. The criteria help ensure that researchers
will be able to answer the questions they plan to study.
(Source: National Institutes of Health)
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