Clinical Research Trials
Carey Cullinane, MD, MPH
Clinical research permits doctors and researchers to find new and better ways to understand, detect, treat and prevent
illnesses such as breast cancer. Much of what we use today in the surgical and medical treatment of cancer and many
of the things that we know about the risks associated with and prevention of breast cancer, we learned through clinical
research trials. For the patients of the future, many of the medications that we will use in the years to come will be part
of today's clinical research trials as we strive to understand how they work for different populations and types of breast
cancer.
We are devoted to finding new and better ways to prevent, diagnose and treat breast cancer. For this reason, we are
committed to offering clinical research trials to patients who may be eligible and consider them vital in the quest for
finding new, effective treatments and cure.
There are many different types of clinical research trials. Some involve collecting historical or family information about
possible risk factors; some involve testing or studying a medical drug or medical device; and some test a new method
of surgery or radiation to see if they are safe and effective. Clinical trials of experimental medications proceed through
four phases:
Phase I clinical trials test a new drug or treatment for the first time in a very small group of patients
to evaluate safety and determine a dose range and the sort of side effects that may be experienced. This initial phase
is done in a small group of patients usually ranging in size from 20 to 100. The study determines how the drug is absorbed,
metabolized and excreted, and treatment is stopped if side effects get too severe.
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In Phase II clinical trials, the study drug or treatment is given to a larger group of people to evaluate
effectiveness and monitor the side effects. Most Phase II trials are randomized trials that compare the experimental
treatment against standard treatment or placebo. In this way, the study can provide comparative information about the
relative safety of the new treatment.
Phase III studies use the study drug in large groups of patients, usually several hundred to several
thousand. This large-scale testing confirms effectiveness, safety, benefits and the range of possible side effects. Most
Phase III trials are randomized and blinded. Once a phase III trial is completed the pharmaceutical company can request
Food and Drug Administration (FDA) approval for marketing the drug.
Phase IV studies are done after the drug or treatment has been marketed. These studies continue to
test the study drug or treatment to collect information about its effect in various populations and to gather side effects that
may be associated with long-term use.
What does it mean when studies are "blinded" or "masked"?
These types of studies usually compare one medication
to a placebo (a harmless "sugar pill") or a standard treatment. In a blinded study the participants do not know which one
they are receiving, and in a "double-blind" study neither the participant nor the study staff members know who is receiving
the study drug and who is receiving the placebo or standard treatment. Studies like this
are performed so that patients and doctors cannot influence the result of the study based upon expectations.
Is participation in a clinical trial safe?
Drugs used in clinical trials must first be proven to be safe and effective for people
before the FDA can approve them and doctors can prescribe them. The FDA has strict rules
that govern how clinical trials are conducted and rules that are designed to ensure the safety of those who participate. There
are well-known risks that are associated with standard therapy. Since there has been less experience with new treatments, not
all of the risks can be anticipated ahead of time. For the most part, the individuals who designed the trial believe that the
treatments offered are as good as or better than the current standard treatment, and participants are monitored very closely. Clinical
trials often provide the best care available. By participating, you might have the opportunity to be one of the first to receive
the benefit of newer treatments.
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Why participate in a clinical trial?
There are lots of reasons to participate in clinical trials. For some, the opportunity to access
a medicine that is not yet available for their disease may provide additional or better treatment. The process of collecting
information from you in the study is designed to find out more about the medication's affect on the disease and the effects
on you. Alternatively, a trial may not benefit you directly, but the information gathered may be of help to other patients with
the same condition. Many patients derive satisfaction from knowing that they are part of the effort to potentially help other
people.
Will I have to pay to participate or will my insurance cover the costs?
Registry studies, those that involve only collection of
information about your family or risk factors, usually do not charge for participation. Some studies, particularly those that
are looking at newer therapeutic modalities, have a sponsor such as a pharmaceutical company or a biotechnology company
that will pay for the drug or device being tested. Rarely do they cover the cost of routine hospital and doctor visits, x-rays
and blood tests. Whether your health insurance provider covers any of these costs depends upon the particular plan that
you have and the study that you would like to participate in. It is best to discuss this with the doctor or nurse which talks to
you about the trial and your insurance company before starting the trial. In addition, if you have to travel to a center far
away from your home, be sure to include this in your estimated cost.
Enroll in a Clinical trial at Breastlink
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