 Research
and Development
Over the past few years, a large and
growing number of persons want to learn more about clinical research
and how to participate in a clinical trial. This page provides a brief
overview of the process. For a dictionary of commonly used terms in
clinical research, Click here
>> Listing of the trials for
which Dr. Mandel is currently recruiting subjects.
What is a clinical trial?
A clinical trial is a carefully designed study that is done with
people who volunteer to receive investigational treatments or
medications that have been developed by biotechnology or drug
companies. Before medications are given to people, they are first
studied carefully in the laboratory. If favorable results are seen,
then a research plan, called a protocol is designed to study the
medication
These companies then select doctors who are qualified to conduct the
clinical trial as investigators. All clinical trials are reviewed by
the U.S. government’s Food and Drug Administration (FDA) and an
Institutional Review Board (IRB). An IRB is an independent committee
whose job is to make sure your rights are fully protected and that you
are not exposed to any unnecessary risks.
The investigator who enrolls patients and oversees their care during
the clinical trial must be sure the information is understood.
Participants are asked to read and sign a paper called an informed
consent form. This form contains information about the possible
benefits and risks of the treatment, the planned procedures a
participant must undergo as part of the clinical trial, and a list of
other available treatments. This form should not be signed until all
questions about the research study have been answered satisfactorily.
Once you have enrolled in a study, you may receive a physical
examination and have your medical history taken by a member of the
research team. Healthcare professionals that conduct clinical trials
are committed to providing you with quality patient care and medical
attention. You should feel free to discuss your medical treatment with
your study doctor or any member of the research staff at any time
during the course of the clinical trial. As a volunteer, you have the
right to leave the study at any time and for any reason.
Your safety is the number one priority. It is important that you take
your medication as prescribed, keep your scheduled visits, and answer
the investigator’s questions about your health. The investigator needs
to record any symptoms no matter how minor they may appear to you.
Your input is valuable and important.
As a volunteer in a clinical trial, you can aid in the development of
medical therapies that may offer better treatments or even cures for
diseases. |
