| A clinical trial is a strictly monitored process. Before a pharmaceutical
company can initiate testing in human subjects in a hospital or clinical
setting, it must conduct extensive pre-clinical or laboratory research. This
research typically involves years of experiments in animal and human cells. The
compounds are also extensively tested in animals. If this stage of testing is
successful, a pharmaceutical company provides this data to the Food and Drug
Administration (FDA), requesting approval to begin testing the drug in humans.
This is called an Investigational New Drug application (IND). Before enrolling
in a clinical trial, you will undergo the informed consent process. At this
time, the investigator will explain the purpose of the trial, its expected
benefits, any possible risks or side effects, and what your role will be. This
is the time to ask questions! If you want to join the trial, you must sign the
informed consent documents. You can leave a clinical trial at any time without
penalty, even after signing the consent forms.
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| Clinical trials have four distinct phases: |
| Phase One |
| trials use a small number of human subjects to test a new treatment that has
already undergone rigorous testing on animals. Participants usually have
advanced disease that hasn’t responded to standard treatments. At this stage,
researchers can only predict outcomes and any possible side effects on humans.
During Phase One trials, investigators determine the most effective dosage and
application methods. Some disease patients have seen improvement in Phase One
trials.
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| Phase Two |
| trials involve a larger group of patients, in which researchers build on what
they learned in Phase One. Because more subjects are involved, investigators
may discover less common side effects, and will continue to evaluate the safety
of the treatment.
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| Phase Three |
| trials may involve over a thousand patients, often at several medical
institutions. During this phase, the study treatment is compared to and/or
combined with standard modalities (treatment methods). Some participants, the
"treatment group," are given the experimental treatment and others in a
"control group" are given the current standard treatment, so researchers can
compare outcomes in the two groups.
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| Phase Four |
| trials occur after the treatment has been put on the market to monitor effects
of long-term usage, and how it affects certain population groups. If dangerous
side effects are found, the drug or treatment is taken off the market.
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| Choosing a Clinical Trial |
| Before participating in a clinical trial, discuss it with your doctor or
disease specialist. Make sure to get all the details of the intended benefits
and possible side effects before signing any consent forms. You can leave a
clinical trial at any time, and will not be penalized for doing so.
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| Here are some issues to consider before enrolling in a
clinical trial: |
| Eligibility - clinical trial investigators follow strict
criteria to recruit study volunteers. Recruitment forms list "inclusion
criteria": things like disease type, treatment status, medical history, age
range, gender, ethnicity and other factors necessary to join the trial. Forms
may also list what investigators aren’t looking for, known as "exclusion
criteria."
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| Benefits - although clinical trials offer no guarantees,
scientists have a strong belief that the study drug or treatment will provide
benefits equal to or better than standard care methods. If that is the case,
study volunteers will be the first to receive this new modality, and will
continue to receive medical checkups to monitor their progress.
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| Risks - the clinical trial process is not risk-free. Study
investigators have anticipated many of the side effects, but not all can be
known ahead of time. If a new treatment exhibits potentially dangerous side
effects, the trial is immediately discontinued and participants receive
follow-up care to ensure they were not harmed. Remember, most standard disease
treatments do have side effects, which include nausea, hair loss and
compromised immune systems.
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| Duration - clinical trials can last anywhere from a few weeks
to several years. Some require frequent clinic or hospital visits, which can
interfere with your normal routine; others only need monthly or quarterly
monitoring. Some studies, particularly Phase Three, are conducted at several
locations, but if you don’t live near a trial site, you may have to consider
long travel times or temporary relocation to participate.
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| Cost - It is essential to determine what your out-of-pocket
expenses will be in a clinical trial before enrolling! You may be responsible
for some or all of the costs involved, including blood work, X-rays, and other
procedures. Sometimes, a biotechnology or pharmaceutical company or other
research grant will sponsor a clinical trial and pay some, but usually not all
expenses. Note: Usually in Canada all costs are covered in a clinical trial.
Some clinical trials will even pay you to be in them. Check with the trial
administrator first. |
| You also need to call your health insurance carrier or
managed care provider to see whether they cover clinical trials. Insurance
companies may deny coverage if the treatment is considered experimental, but
they might pay if the study treatment is similar to something the patient would
receive outside a clinical trial.
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