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Will You Have Access to Those Drugs That
Work After a Trial Is Complete?
Often, the company developing a new drug may try to see
that you can continue to get it, even before the FDA has
approved it for sale. You may be able to do this under
what is termed a compassionate plea basis. This means
that because the new drug has been so helpful, the
manufacturer can give it to a physician, who may then
prescribe it for you.
While companies often make such a new drug available,
there may also be good reasons why a company cannot.
Perhaps only a very small amount of a drug was prepared
for the research project, and no more is available for
use afterwards. Then again, a manufacturer may want to
further test the drug under certain conditions, or to
examine the results of a research study more fully
before releasing it for compassionate plea use. A
company would be especially careful if a new medication
required that the doctor who prescribed it have some
special knowledge or skill to monitor its safe use.
You and any family members interested in your well-being
should discuss with the director of the research your
questions about compassionate plea use. Each case is
different, so the agreement has to be between the drug
manufacturer and your own doctor.
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Studies of new drugs often compare the
effects of an investigational drug with the effects of a
placebo. If you are considering whether to take part in
a drug trial, the director of the study must tell you if
the study will use a placebo control. The informed
consent form that you will sign if you agree to join the
study must also explain any plans to use a placebo
control.
The reason for using a placebo control is that the
benefits from taking medications are not always due to
the drug itself. These benefits are called "placebo
effects." An example is when an investigator's
enthusiasm about a new medication sometimes influences
the patient's response.
A researcher must be able to separate placebo effects
from the actual effects of the drug being studied. When
equal numbers of patients receive either a placebo or
another standard drug that will help treat their
symptoms, the researcher can better judge the actual
effects of the drug being tested.
In a "double-blind, placebo-controlled" research design,
the doctors and nurses working directly with patients in
the study will not know which group patients are in.
Only members of the research team not involved in
providing day-to-day clinical care will know which
patients are receiving an active treatment or a placebo.
This information is shared only when there is a medical
necessity to do so to protect the patient and at the end
of the study.
Some scientists have questioned the use of placebo
controls in clinical research. They argue that if any
drug is effective in treating a given condition, then
only that drug, and not a placebo, should be given as
the control. Other researchers, however, believe that
without a placebo control, it is harder to know whether
an investigational medication is better than existing
drugs. The choice depends on what is being studied, the
medicine, and the illness.
If, during a study, an investigational drug seems to
work very well, the researcher may stop using the
placebo. In some instances, participants may have a
chance to use the investigational drug after a study is
completed.
It is important that the director of a medication trial
explain thoroughly any planned use of a placebo. Ask how
the researcher plans to keep track of your symptoms.
Also, ask if there is a possibility that your symptoms
could become severe during the research project. If your
symptoms worsen, at what point will the researcher
decide to remove you from the study and provide standard
treatment? In talking about these possibilities with the
researcher, you must remember that participating in a
study does not guarantee that you will receive a
promising new medication. Indeed, you must consent to
that fact. Also, you should remember that even if you
receive an investigational drug, it may not be helpful
for you. Remember you can always withdraw from a study.
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In most informed consent forms, the
researcher promises to share what is learned from the
study with you. These results will sum up the responses
of everyone who took part in the study. In addition, the
researcher will discuss with you any results that relate
to your diagnosis or that may be useful in deciding on
the best treatment for your disorder.
Be sure to ask the director of research when you can
expect to hear about the results. Ask how you will get
this information. Will the researcher write an article
describing the study, or will those who took part be
invited to a meeting with the study director when all
the results are in? If you have questions about the
results when you receive them, ask the researcher who
can help you to understand what they mean.
A frustrating thing about research is that it often
takes years before the results of a study are available.
This is because of the time it takes to conduct the
study, including getting enough people in the study to
make the results meaningful. Be patient, but remember to
ask for the results if you have not received them when
you expected them.
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