Frequently Asked Questions
(Source:
National Institutes of Health)
For those considering participation
in a clinical trial, the following frequently asked
questions are important in understanding the role
of the participant and the unique process of clinical
trials.
It is important to note that before
enrolling in a clinical trial, the research physician
or nurse will fully explain the purpose of the study
and all study-related activities. This detailed
explanation is part of a process called the informed
consent.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial
being conducted. The clinical trial team includes
doctors and nurses, as well as other health care professionals.
They check the health of the participant at the beginning
of the trial, give specific instructions for participating
in the trial, monitor the participant carefully during
the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor
visits than the participant would normally have for
an illness or condition. For all types of trials, the
participant works with a research team. Clinical trial
participation is most successful when the protocol
is carefully followed and there is frequent contact
with the Research Team.
Why should I participate?
The health of millions has been improved because of
advances in science and technology, and the willingness
of thousands of individuals like you to take part
in clinical research. The role of volunteer subjects
as partners in clinical research is crucial in the
quest for knowledge that will improve the health
of future generations. Without your help, the research
trials at the Jim Moran Heart and Vascular Research
Institute cannot be accomplished.
What are Phase I, Phase II and Phase III trials?
The Phase I study is used to learn the "maximum
tolerated dose" of a drug that does not produce
unacceptable side effects. Patient volunteers are followed
primarily for side effects, and not for how the drug
affects their disease. The first few volunteer subjects
receive low doses of the trial drug to see how the
drug is tolerated and to learn how it acts in the body.
The next group of volunteer subjects receives larger
amounts. Phase I trials typically offer little or no
benefit to the volunteer subjects.
The Phase II study involves a drug whose dose and side
effects are well known. Many more volunteer subjects
are tested, to define side effects, learn how it is
used in the body, and learn how it helps the condition
under study. Some volunteer subjects may benefit from
a Phase II study.
The Phase III study compares the new drug against a
commonly used drug. Some volunteer subjects will be
given the new drug and some the commonly used drug.
The trial is designed to find where the new drug fits
in managing a particular condition. Determining the
true benefit of a drug in a clinical trial is difficult.
What is a placebo?
Placebos are harmless, inactive substances made to
look like the real medicine used in the clinical trial.
Placebos allow the investigators to learn whether the
medicine being given works better or no better than
ordinary treatment. In many trials, there are successive
time periods, with either the placebo or the real medicine.
In order not to introduce bias, the patient, and sometimes
the Research Team, are not told when or what the changes
are. If a placebo is part of a study, you will have
an Informed Consent Form given to
you before you agree to take part in the study. When
you read the consent form, be sure that you understand
what research approach is being used in the study you
are entering.
What is the placebo effect?
Medical research is dogged by the placebo effect -
the real or apparent improvement in a patient's condition
due to wishful thinking by the investigator or the
patient. Medical techniques use two ways to rid clinical
trials of this problem. These methods have helped discredit
some previously accepted treatments and validate new
ones. Currently accepted methods used are: Randomization
and Blinded Trial Design
What is randomization?
Randomization is when two or more alternative treatments
are selected by chance, not by choice. The treatment
chosen is given with the highest level of professional
care and expertise, and the results of each treatment
are compared. Analyses are done at intervals during
a trial, which may last years. As soon as one treatment
is found to be definitely superior, the trial is stopped.
In this way, the fewest number of patients receive
the less beneficial treatment.
What are blinded trials?
In single- or double-blind trials, the participants
don't know which medicine is being used, and they can
describe what happens without bias. Blind trials are
designed to prevent anyone (doctors, nurses, or patients)
from influencing the results. This allows scientifically
accurate conclusions. In single-blind trials,
only the patient is not told what is
being given. In a double-blind study,
neither the doctors, nurses, patients, or other health
care staff know what is being given. In double-blind
studies, only the pharmacist has that information.
If medically necessary, however, it is always possible
to find out what the patient is taking.
Are there risks involved in participating in clinical
research?
Risks are involved in clinical research, as in routine
medical care and activities of daily living. In thinking
about the risks of research, it is helpful to focus
on two things: the degree of harm that could result
from taking part in the study, and the chance of any
harm occurring. Most clinical trials pose risks of
minor discomfort, lasting only a short time. Some volunteer
subjects, however, experience complications that require
medical attention. The specific risks associated with
any research protocol are described in detail in the Informed
Consent Form which you are asked to sign before
taking part in research. In addition, the major risks
of participating in a study will be explained to you
by a member of the Research Team and will answer all
of your questions about the study. Before deciding
to participate, you should carefully weigh these risks.
Although you may not receive any direct benefit as
a result of participating in research, the knowledge
developed may help others.
What safeguards are there to protect participants
in clinical research?
The following section describes safeguards that protect
the safety and rights of volunteer subjects. These
safeguards include:
8 The Protocol Review
Process
8 Informed Consent Procedures
8 The Patient Representative
Protocol review. As in any
medical research facility, all new protocols designed
at HCRC must be approved by an institutional review board
(IRB) before they can begin. The IRB, which consists
of medical and non-medical professionals with experience
and training in the ethical conduct and oversight of
clinical trials, is the advocate of the volunteer subject.
The IRB will only approve protocols that address medically
important questions in a scientific and responsible manner.
Informed consent. Your
participation in any Holy Cross Research Center research
protocol is voluntary. For every
study in which you intend to participate, you will receive
a document called "Consent to Participate in a Clinical
Research Study" that explains the study in straightforward
language. A member of the research team will discuss
the protocol with you, explain its details, and answer
your questions. Reading and understanding the protocol
is an important responsibility. You may discuss the protocol
with family and friends. You will not be hurried into
making a decision, and you will be asked to sign the
document only after you understand the
nature of the protocol and agree to the commitment. At
any time after signing the protocol, you are free to
change your mind and decide not to participate further.
This means that you are free to withdraw from the study
completely, or to refuse particular treatments or tests.
Sometimes, however, this will make you ineligible to
continue the study. If you are no longer eligible or
no longer wish to continue the study, you will return
to the care of the doctor who referred you to HCRC.
Patient representative. The Patient Representative
acts as a link between the patient and the hospital.
The Patient Representative makes every effort to assure
that patients are informed of their rights and responsibilities,
and that they understand what the Holy Cross Research
Center is, what it can offer, and how it operates. We
realize that this setting is unique and may generate
questions about the patient's role in the research process.
As in any large and complex system, communication can
be a problem and misunderstandings can occur. If any
patient has an unanswered question or feels there is
a problem they would like to discuss, they can call the
Patient Representative.
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