Although mesothelioma currently has no cure, there are many clinical trials underway to test new drugs and find more effective treatments to fight against the disease. Clinical research trials are studies completed with the help of human volunteers. They are often the last steps before a drug, procedure, or tool can be released to the medical community as safe to use. By participating in a clinical trial, a mesothelioma patient can gain access to groundbreaking therapies, new chemical treatments, and advanced techniques that are not yet available to the general public. Eligibility requirements for mesothelioma clinical trials can include factors such as age, gender, the type and stage of the disease, previous treatment history, and additional pre-existing medical conditions.
The purpose of each step of the clinical trial is to validate that a treatment is tolerable, that it has an effect worth pursuing, and that it is equal to or better than existing treatments. There are three phases of clinical trials that correspond to these steps. During the three phases, a drug or treatment is studied before it can be eligible for approval by the FDA (Food and Drug Administration).
Phase I Trials: Phase I trials seek to establish an upper safe limit for the treatment and monitor for side effects. In order to do this, each group of patients in the study is given a higher dose than the last. This process is repeated group by group until a percentage of the participants experience enough negative side effects that a higher dosage for the next group would be inadvisable. There are usually at least three patients in each group. Generally speaking, in order to be eligible for a Phase I clinical trial, patients must be capable of metabolizing and excreting the drug and have a projected life expectancy of at least 1-2 months.
Phase II Trials: Phase II trials administer the new drug or treatment to larger groups of patients in order to find out if the treatment is effective. In most Phase II trials, all participants receive the same dosage of the drug. Researchers continue to monitor the safety of the treatment and any side effects it may cause. Participants in the trial are closely observed for an anticancer effect by measurement of cancer sites present at the beginning of the trial. Eligibility requirements for Phase II trials vary but participants are generally required to have adequate organ function, at least a three month life expectancy, and a limited number of prior treatments.
Phase III Trials: Phase III trials are given to an even larger group of patients. They attempt to confirm the effectiveness of the treatment, monitor for undesirable side effects, compare the new treatment to existing treatments, and collect additional information that will ensure that the experimental drug or treatment is used safely.
When a Phase III trial is concluded, the researchers analyze the data they have collected and determine if the results have medical relevance. If the results of this analysis are positive, the drug is submitted to the Food and Drug Administration (FDA) for approval. In some cases, Phase IV trials are conducted after the release of a treatment in order to continue to monitor its effectiveness and safety. These trials are also known as Post Marketing Surveillance Trials.
Choosing a mesothelioma clinical trial is an important decision that should be made with your doctor and your family. Mesothelioma patients who are interested in participating in a clinical trial should speak with their doctor in order to make an educated decision about which trial is right for them. Before signing the informed consent form, it is advisable to ask questions and make sure you fully understand the risks involved. Listed below are some questions to consider if you are interested in participating in a clinical trial:
Your doctor and the clinical trial coordinator will be able to answer these questions and determine if you are a good candidate for participation.
There are several key benefits and drawbacks involved in clinical trials that should be carefully considered by mesothelioma patients. One potential drawback to participating in a clinical trial for mesothelioma is that many of them are conducted at large cancer centers. Depending on the location of the trial, extensive traveling may be required in order to receive the necessary treatments and undergo tests. In addition, since the safety of the treatment is still being tested, participants may experience side effects that could range from being uncomfortable to life-threatening. However, an important benefit of participating in a clinical trial is that the patient will be receiving care from leading cancer physicians in advanced facilities. Finally, although the patient will have access to new, groundbreaking drugs and treatment protocols, they may ultimately prove to be ineffective in the treatment of mesothelioma.
Those considering mesothelioma clinical trials should also evaluate their legal options. Mesothelioma patients and their families have a right to seek compensation for medical bills, pain and suffering and emotional anguish, from the company responsible for the asbestos exposure. Fill out our free case evaluation form today to speak with a mesothelioma lawyer.
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