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
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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