Learn More About
Clinical Trials
What is a
Clinical Trial?
How is a Study
Conducted?
How is a Patient's
Safety Protected?
What is a Clinical
Trial?
Before a new medication
can be sold in the United States, it has to be approved
by the Food and Drug Administration (FDA), a federal
agency responsible for the safety of all drugs available
to the public. In order to prove the safety and
effectiveness of new medications, pharmaceutical
companies sponsor special studies. These studies are
called clinical trials.
New medications evaluated
in three phases:
Phase One is
conducted on small group of volunteers, usually in a
hospital, to determine how the medication affects
the body.
Phase Two is
conducted on patients who have a specific health
problem that the new medication is designed to
treat. The purpose of Phase Two is to determine if
the medication is effective against a specific
condition and to uncover risks and side effects.
Phase Three is
conducted on large groups of patients. It provides
additional information about the drug's
effectiveness and side effects. Following Phase
Three, the drug is usually submitted to the FDA for
approval of its commercial use.
The FDA carefully
evaluates the results of each phase of the study before
authorizing pharma companies to conduct the next phase.
In some cases, the FDA requires additional studies (Phase
Four) to obtain information about long-term effects
of already approved medications. Sometimes, Pharma
companies also conduct additional studies to compare
effectiveness of already approved and marketed drugs.
While no two trials are
identical, there are two common types of studies:
double-blind and open-label.
In a double-blind
study, a patient is given either an investigational
medication, a comparable already approved
medication, or a placebo. Neither the patient, nor
the staff of the research center knows what the
patient received. Double-blind studies are designed
to evaluate the efficacy of the new medication or
treatment. They tend to be shorter in duration and
require fewer patient visits.
In an open-label
study, the patient knows what medication he or she
is taking. Open-label studies are usually
long-term. They are often conducted with the same
patients who participated in initial double-blind
study of the medication.
How is a Study
Conducted?
Participation in clinical
trials is strictly voluntary. At the first visit, we
will ask you to read and sign a Consent Form. It is a
document providing description of the study, known
possible risks and side effects, and alternative
treatments and benefits. Please read the form
carefully. Be sure to ask any questions you may have to
fully understand the Consent Form and to discuss any
concerns you may have. You should never feel pressured
to participate in a study.
Following the signing of
the form, you will undergo a physical examination, often
including blood work and other diagnostic procedures, to
determine whether you are eligible to participate in the
study.
You will then be given
the study medication as well as detailed instructions on
how to use it. Depending on the study, you may need to
see us several times to monitor the effects of the
medication. You may also be asked to keep a diary or
report your condition over the phone.
How is a Patient's Safety
Protected?
No medication (even those
sold without prescription) is 100% safe. One of the
purposes of clinical trials is to uncover possible side
effects and risks of the investigational medication. To
the best of the sponsoring pharmaceutical company's
knowledge, the known risks will be presented to you in
the Consent Form. We encourage you to read the Form
carefully and to discuss your concerns with the study
personnel.
Here are some of the
measures that are in place to reduce the risks
associated with clinical trials:
All studies of new
medications are subject to FDA regulations. The FDA
monitors the clinical trials and allows the studies
to proceed only after careful evaluation of the
known risks and benefits. We conduct our trials in
full compliance with the FDA regulations
All studies involving
humans require review, approval, and ongoing
monitoring by an Institutional Review Board (IRB).
IRBs are independent committees specifically charged
with the responsibility of protecting the rights and
well-being of the study participants. Every trial
conducted by BCT is IRB approved
Pharmaceutical
companies continuously monitor the results of the
studies and notify FDA and the research centers
immediately if any serious side effects occur. In
turn, the study doctor or nurse will be in touch
with you immediately if any such event takes place
We advise and encourage
you to report and side effects or changes in your
condition ASAP. In serious cases, you should seek
medical care immediately.
