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Frequently Asked Questions
(En Español)
For many
of us, the idea of joining a clinical
research study may be exciting, yet
unfamiliar. Questions that can arise
in the process of deciding on joining
a study include:
What
is a clinical research study? A
clinical research study is conducted by
qualified doctors to evaluate a new investigational
treatment for a certain illness. Before
any investigational treatment is given to subjects in a
clinical research study, it is researched
in the laboratory. Clinical research studies
provide a way to test experimental treatments.
All treatments in widespread use today were
first proven effective and safe in clinical
studies.
Why
do people enroll in a clinical study?
Many people find that assisting in medical
research is rewarding because they:
- Receive a comprehensive,
study-specific physical examination at
no cost. Subjects also receive study-related
medical care, including blood tests, other
relevant laboratory work and follow-up
study-related care. Study participants
may receive a copy of their exam results
by completing a consent form to release
medical information.
- Can help bring new medical
treatments reach widespread use, and advance
scientific knowledge.
- Are interested in receiving
new, potential therapies that are not
available to the public.
- Gain personal satisfaction,
knowing that their involvement may improve
the quality of life for patients suffering
from chronic disease or illness.
- Often get a stipend or
compensation (money for their time and
efforts relating to a study.
Are
there any risks of participating in a clinical
research study? There are potential
risks in every research study. In clinical
studies, some patients may experience side
effects from the investigational drug. An
informed consent form, which every subject
must understand and sign before enrolling,
lists the possible risks and side effects
which may be experienced. Some subjects
may receive placebo (inactive substance),
and their condition may not change or may
even worsen.
What
does informed consent mean? Informed
consent is the process by which volunteer
subjects learn about the details of their
clinical trial. Subjects must be provided
all facts about a trial prior to giving
consent to participate, including treatment
details and possible risks and benefits.
The informed consent form must be signed
by patients prior to participation, but
the informed consent process continues throughout
the clinical trial.
Who
can participate in clinical trials?
Each study is designed for a particular
group of people, whose ability to participate
is based on detailed set of criteria. These
criteria include age, health, disease history,
and lifestyle factors. Adults with a clean
bill of health may be subject in ‘healthy
volunteer’ trials, while people with
existing medical conditions may be subjects
for ‘patient’ trials.
What
should I expect when enrolling in a study?
Counseling: You will be counseled
regarding the requirements and expectations
related to a specific study, including the
benefits and risks of study participation.
CNS staff consists of experienced physicians
(MD's), physician specialists, registered
nurses and clinical research professionals.
Our staff maintains relationships with community-based
physicians and local health advocacy organizations.
We often provide our patients with support
information, educational material and referral
services.
Informed Consent: You will
be given materials to review as you reach
a decision about participation. Although
CNS' research staff will inform you of any
risks or potential side effects, it is very
important that you ask questions and read
the consent form. Make sure that you fully
understand and feel comfortable with the
nature of the study medication, the types
of procedures to be performed, and what
is required of you as a volunteer. You will
have the opportunity to ask questions and
discuss all aspects of your participation
with CNS staff. Your participation begins
after you sign the informed consent document,
indicating that you understand the important
features, risks, and benefits related to
your participation in a particular study.
Assessments and Medication:
Once you are enrolled in a study, you will
receive a study-related physical exam, study
medication, laboratory tests, and study
procedures as necessary, typically at no
cost to you. During the course of the study,
medical personnel will meet with you to
monitor your progress. Our medical professionals
have extensive experience in evaluating
investigational medications and working
with treatment-related procedures. These
medical personnel will communicate with
your primary doctor as appropriate. Your
relationship with your usual doctor(s) does
not change during, or after your participation
in a study.
After the Study: Any information
you and your usual doctor(s) would like
to receive related to your participation
can be shared, after you give your written
consent.
Would
my participation in clinical trials affect
my relationship with my doctor?
We encourage you to speak to your physician
about your interest in a clinical research
program. In addition, our doctors and their
staff are happy to consult with your physician
about your participation in a study, or
about the medical requirements for a study.
CNS staff does not replace your healthcare
providers, but works with them to enhance
all of your healthcare options. At your
request, your study-related medical records
can be shared with your physician. You may
be asked to sign a medical release form
so that your medical information may be
shared between your family doctor and the
clinical research study doctor. Participation
in a research study is completely voluntary.
You may decide not to participate or withdraw
from a research study at any time without
compromising your future medical care.
How
do I participate in a clinical research
study? To learn more about participating
in a clinical study, click
here. Or to contact a CNS research center
directly, click
here. When contacting CNS, you will
be greeted by a clinical research coordinator
who will ask you a series of questions regarding
your current health condition or disease
state. All of our clinical research coordinators
are healthcare professionals trained in
clinical research. If you qualify to participate
in a currently enrolling study based on
the information you provide, the clinical
research coordinator will schedule an appointment
for you to be evaluated by a CNS doctor
at a time convenient for you. If you do
not qualify for a study at that time, we
may contact you regarding future clinical
research studies.
Will
participation in a clinical study cost me
anything? In most studies, study-related
medical examinations, investigational medications
and laboratory tests as listed in the clinical
study plan, are provided at no cost to you
as long as you are a research study participant.
Medical insurance is not necessary, and
some studies offer compensation for participation.
Participation in a clinical study is completely
voluntary, receiving compensation does not
change your ability to leave the study at
any time.
Am
I guaranteed to get real medicine?
While some research study participants receive
investigational study medication, some research
study participants will receive placebo
(inactive substance). You will learn more
about this when you visit the clinical research
location.
Who
conducts clinical studies at the research
centers? The professional staff
at CNS consists of physicians (MDs), physician
specialists, registered nurses and clinical
research professionals. Our medical professionals
have experience in evaluating investigational
medications and treatment procedures. Our
staff maintains relationships with community-based
physicians and local health advocacy organizations.
Patients are provided not only with clinical
study specific information, but may also
be provided with educational materials and
referral services.
Will
my insurance/provider pay for the clinical
trial expenses? Not always. Make
a point to find out up front whether your
health insurance or managed care provider
will cover the costs of a particular clinical
trial. Speak with one of the clinical trial
doctors about cost issues before you volunteer
as a participant.
Will
I be compensated? Compensation
varies from study to study, and is determined
by the length of stay and any additional
requirements placed upon the volunteer subject.
What
kind of time commitment is involved?
All studies vary in structure and length
of commitment. Some studies may involve
a single in-house stay, or may be entirely
performed as you remain an out-patient.
Others may have multiple or longer stays,
follow-up visits or require additional activities,
such as keeping a study diary.
How
often can I participate? Generally
speaking, upon completion of a trial (including
any follow-up visits), you may be eligible
to participate in another study in as little
as 30 days. Some protocols require a 60
or 90-day period before participating again.
This ‘wash-out’ period allows
the investigational medication(s) to be
completely eliminated before introducing
another research medication into the body.
Who
will see my records? Under law,
CNS is required to keep all volunteer records
confidential. Medical information obtained
in clinical trials is handled with the strictest
confidence is not made publicly available,
to the extent permitted by applicable laws
and/or regulations. Only employees of the
FDA or other government authorities, the
sponsoring company or their representatives
and CNS, or members of a special study safety
board (Institutional Review Board or IRB)
may review the records and information collected
during the study. The FDA and IRB require
that personal information, such as your
name, contact information, and social security
number, cannot be disclosed with your trial
results. Instead, initials and/or assigned
numbers will be used on all materials and
data. Your anonymous information will be
reviewed by staff members of the sponsoring
drug company to determine the effect of
an investigational medication's on patient
safety. In addition, all results are reviewed
by the FDA on a regular basis.
How
are subjects protected? Clinical
trial studies are developed to ensure that
patients are not put at undue risk. These
studies are carefully reviewed by a committee
of experts and community representatives,
called an Institutional Review Board (or
IRB), before testing can commence. As a
volunteer, you have the right to refuse
treatment at any point in the clinical trial
and leave at any time and for any reason.
If doctors discover that the study treatment
is harmful to you, you have the right to
leave the trial and return to your doctor's
care.
What
is CNS or Comprehensive NeuroScience?
CNS is company comprised of medical research
facilities located across the country. The
company works with different clients to
conduct clinical research studies. CNS has
experience conducting hundreds of clinical research studies by working
with thousands of patients in the study of
investigational medications throughout the
United States.
What
questions should I ask before I agree to
be in a clinical trial? You have
the right to ask any number of questions
of the clinical trial doctors and sponsors
prior to volunteering. Here are some areas
to consider:
- What is the purpose of
the clinical trial?
- Who is sponsoring the trial?
- Who has reviewed and approved
it?
- Has the drug or treatment
in this trial been tested before? What
were the results?
- Where will the trial take
place and how long will it last?
- Do I have to stay in a
medical facility during the clinical trial?
- What kinds of tests and
treatments will be given? How often? Are
they painful?
- Will my medical records
be kept confidential?
- Who will see the trial
results?
- How will I know if the
treatment is helping me?
- Are there any risks or
side effects expected from any part of
the trial?
- If I am harmed in any way
by the research, what medical care will
I be entitled to?
- Are there treatment alternatives?
How do they compare with what the trial
offers?
- Will I still be able to
see my own doctor during the trial?
- Is the care I receive during
the trial free? If not, will my insurance
cover it?
- If the treatment works
for me, can I stay on it after the clinical
trial is over?
- Is there any long-term
follow-up care scheduled as part of the
trial?
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