Mesothelioma Clinical Trials: An Overview
Mesothelioma Clinical Trials: An Overview
Mesothelioma Clinical Trials: An Overview
Mesothelioma clinical trials are a
continual process, with experts and medical professionals working hard
to try and find an effective, long term treatment for victims of this
deadly cancer.
Resulting from exposure to asbestos fibres, mesothelioma
is a cancer that can affect various parts of the body. Most commonly,
it affects the lung and respiratory area, but can also affect the
abdominal region and the heart. This cancer has a very long latency
period, and symptoms may not show for several decades following exposure
to asbestos. It is a disease that is notoriously difficult to diagnose
due to its non-specific symptoms, and is equally hard to treat as there
is currently no long term treatment available.
Through clinical trials, which are
carried out all over the world, it is hoped that an effective treatment
can be found that will stop this disease from being a terminal one.
There have been some breakthroughs in terms of short term treatments and
diagnostic tests, but a long term treatment is yet to be found.
Clinical trials are no guarantee of successful treatment. However, they
are normally performed with substances and medications that researchers
believe to have some positive effect following lab and animal testing.
Clinical trials may differ from
state to state, and anyone wishing to be part of a trial will need to
meet the set criteria, which can again differ from state to state. The
trials can be held as out-patient hospital treatments or within cancer
research units, depending on the location.
There are generally three phases
involved in clinical trials, and all three phases must be successful
before the FDA (Food & Drug Administration) can consider approving
the drug or treatment. These stages are:
Phase I: This
takes place after lab and animal testing has been successfully
performed. However, during this stage the effects on human patients of
the drug or treatment being tested needs to be closely monitored. This
stage is also used to determine the best method of administration of the
drug, and how much can be administered safely.
Phase II:
Following the evaluation of the safety of the treatment (during phase I)
this phase assesses how effective the drug or treatment is. The
patients’ affected areas are carefully monitored to see what effects the
treatment has had on the cancer. Side effects as well as positive and
negative effects are recorded and carefully assessed during this phase.
Phase III: This is
where large numbers of patients are enrolled for testing of the
treatment or drug. There is generally a ‘control group’ who are given a
standard treatment, whereas the test group are given the new treatment.
This enables researchers to compare the effects of the new treatment
against the standard one. Patients are very closely monitored during
this phase, and treatment is stopped upon the onset of any severe side
effects.
There are a number of standard questions that a researcher needs to be able to answer from the results of clinical trials, such as:
Whether the treatment is likely to help patients
Whether the treatment works
Whether the treatment is more effective than other standard treatments available
What sort of side effects the treatment has
Whether the benefits outweigh the risks and side effects
Whether the treatment is likely to help a particular group of patients, and if so which group
Although doctors often recommend joining clinical trials to their
patients (subject to eligibility) it is the patient’s decision as to
whether or not he or she wishes to be part of a test group. Patients
often agree to clinical trials in the hope that they can benefit from a
new treatment as well as help the medical profession to find a drug that
can help others in the same situation. However, refusing to be part of a
clinical trial does not in any way affect the patient’s right to
standard treatment or medication.
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