Clinical Research FAQ
Clinical trials are appealing to many patients because they allow them
to participate in new treatments that will hopefully prove to be more
efficient at curing diseases. However, be aware that these treatments
are not fully tested and there are some risks involved. It is important
that you understand what a clinical trial involves before agreeing to one.
What is a clinical trial?
A clinical trial is a research program conducted in patients to evaluate
a new medical treatment, drug or device. The purpose of clinical trials
is to find new and improved methods of treating different diseases. Clinical
trials make it possible to apply the latest scientific and technological
advances to patient care.
Why participate in a clinical trial?
During a clinical trial, doctors use the best available treatment as a
standard to evaluate new treatments. The new treatments are hoped to be
at least as effective as - or possibly more effective than - the standard.
What are the different types of clinical trials?
Treatment trials test experimental treatments, new combinations of drugs
or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the
disease, or to prevent a disease from returning. These approaches may
include medicines, vaccines, vitamins, minerals or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular
disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality
of life for individuals with a chronic illness.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have
a different purpose and help scientists answer different questions:
Phase I trials, researchers test an experimental drug or treatment in a small group of
people (20-80) for the first time to evaluate its safety, determine a
safe dosage range and identify side effects.
Phase II trials, the experimental study drug or treatment is given to a larger group of
people (100-300) to see if it is effective and to further evaluate its safety.
Phase III trials, the experimental study drug or treatment is given to large groups of
people (1,000-3,000) to confirm its effectiveness, monitor side effects,
compare it to commonly used treatments and collect information that will
allow the experimental drug or treatment to be used safely.
Phase IV trials, post marketing studies delineate additional information including the
drug's risks, benefits and optimal use.
Jupiter Medical Center Participates in Phase II, III and IV clinical trials.
How am I protected as a patient in a clinical trial?
Under the regulations of the Food and Drug Administration, Jupiter Medical
Center has a local Institutional Review Board (IRB) that is designated
to review and monitor biomedical research involving human subjects. The
purpose of the IRB review is to assure that appropriate steps are taken
to protect the rights and welfare of participants in research offered
by Jupiter Medical Center and its medical staff. The IRB is composed of
physicians, clergy, nurses, lawyers and community leaders. Patients participating
in research trials are more closely monitored by their doctors and by
the research nurses.
Should I enroll in a clinical trial?
Deciding whether or not to enroll in a clinical trial involves careful
consideration between patient and physician. Patient-centered, individualized
discussion includes a detailed informed consent, eligibility screening
and education of the benefits and possible risks related to the clinical
trial. Study participants receive ongoing monitoring and follow-up by
the research staff throughout their participation.