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Learn More About
Clinical Trials
Learn More
About Clinical Trials
Copyright Veritas
Medicine
Used here with permission
What are
clinical trials?
Before a new drug or new treatment is
approved by the U.S. Food and Drug Administration (FDA) it must be shown
to be both safe and effective. Typically, this is accomplished via
clinical trials-carefully controlled studies designed to test and
evaluate new drugs and new treatment plans. These trials are carried out
to learn more about the new treatment and to find better therapies.
Why do people
participate in clinical trials?
People may be interested in clinical
trials for a variety of reasons. Some people who are very sick or are
not responding to standard treatments join clinical trials in order to
receive new, investigational treatment. They are hoping that this
treatment-possibly a new drug or a new combination of drugs-will work
better for them than standard therapy. This is not always the case as
new treatments strategies may not work or may have side effects. For
this reason, all people in clinical trials are carefully monitored.
Frequent medical exams and tests are performed to assure their safety.
Other people participate in clinical
trials to contribute to medical science and to help doctors and
researchers find better ways to help others.
Are there risks
in clinical trials?
The process of evaluating new
treatments can involve some risk. All drugs used in clinical trials have
been extensively tested in laboratory experiments. However, some side
effects do not become apparent until the treatments are given to humans.
Side effects can vary from patient to patient. It is important to
remember that clinical trials can carry unknown dangers as well as
possible benefits.
The progress of patients in clinical
trials is constantly monitored. Periodic reviews of test results and
other statistics are carried out while the trial is underway. If, at any
time, a new treatment is found to be harmful to the study participants,
the trial will be terminated.
What is informed
consent?
Before enrolling in a clinical trial,
the doctors and nurses will discuss with all potential participants the
possible risks and benefits involved. These issues are summarized in a
lengthy form that explains the trial procedures and the possible side
effects. This is called an informed consent form and all clinical trial
participants are asked to read, understand, and sign it before beginning
treatment. It is important to ask the doctor or nurse to explain any
part of the form that is unclear.
Can clinical
trial participants leave a trial?
Yes. Even though someone has agreed to
participate in a trial by signing the informed consent form, they are
free to leave the trial at any time.
How are clinical
trials conducted?
The doctors and researchers running a
clinical trial develop a written plan detailing exactly how the trial
will be conducted. This plan, also called a protocol, explains how the
trial will be run, what information will be gathered, and what new
things the researchers hope to learn.
Many clinical trials compare a new
treatment to a standard treatment. In these trials, participants are
divided into two groups. One group receives the new treatment and one
group receives the standard treatment (the "control" group).
Various statistics are then gathered using blood, x-ray, and other tests
to assess how well each group responds to the two kinds of treatment.
In order to prevent biased results or
interpretation, many trials assign participants by chance to one of
these two groups. This process, known as randomization, is only used
when it is not known which treatment option will work better.
Can clinical
trial participants still see their regular doctor?
Yes. Clinical trials do not replace
normal health care. In fact, the regular doctors of trial participants
should be updated regularly by the trial coordinators.
What are the
different phases of clinical trials?
Clinical trials are traditionally
divided into different phases. Each phase is designed to gather specific
information about the drug or treatment being studied.
Phase I trials
These trials are the first human tests
of new drugs or therapies. They typically involve small numbers of
volunteers and are designed to determine the best dose of the drug and
to check for any side effects. Because Phase I trials use treatments
that have never been tested in humans, they may involve significant
risks.
Phase II trials
If a treatment is shown to be safe and
well tolerated, it moves on to Phase II trials. These trials involve
many more volunteers and are designed to see how well the treatment
works, usually in a small group of patients.
Phase III trials
If the treatment is effective in Phase
II trials, it moves on to Phase III trials. Hundreds or even many
thousands of patients may participate in these studies. They are aimed
at further testing how well the treatment works. Often, Phase III trials
compare the new treatment to an already existing, standard treatment, in
a randomized fashion.
Phase IV trials
These trials are conducted after a drug
has been approved by the FDA and is on the market. Phase IV trials
typically involve a very large number of participants and are designed
to evaluate new uses of existing therapies or to detect side effects
that were not apparent during Phase III studies.
Who pays for the
treatment in a clinical trial?
For the most part, the drugs used in
clinical trials are given free of charge to the study participants.
However, there may be other costs associated with the trial, such as
blood work, x-ray tests, and travel expenses. Health insurance may cover
some of these items and some may be offered free of charge. Medicare now
covers all routine patient care costs associated with clinical trials.
The financial details should be discussed prior to enrolling in a trial.
What questions
should be asked about a clinical trial?
The following questions might be
helpful in discussing a clinical trial with a healthcare provider
(Adapted from the NIH booklet What Are Clinical Trials All About?).
- What is the purpose of the trial?
- What kind of tests and treatments
are involved?
- What is likely to happen in my case
with, or without, this new research treatment?
- What are alternative treatment
options and their advantages and disadvantages?
- How might this trial affect my daily
life?
- What side effects might I expect
from the study?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the treatment?
- If I were harmed as a result of the
trial, what treatment would I be entitled to?
- What type of long-term follow-up
care is part of this study?
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