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Mesothelioma is a rare type of cancer that is found typically in the chest and abdominal area. The cancer is mainly caused by excessive exposure to asbestos, though it may take up to 30 or 40 years for the cancer to appear. Once it does appear, it is important for it to be treated quickly or else it could prove fatal. This cancer can be treated by surgery, chemotherapy, and radiation therapy. Despite the various methods available for its treatment, Mesothelioma cancer is not entirely curable, and new research is constantly being done in preparing new drugs and others forms of treatments for this cancer.
Clinical Trials of Mesothelioma
Clinical trials are studies in which people help doctors find better ways to cure the cancer. The objective of the study is to find whether the new approach is effective and safe. When a new treatment is found which seems promising, the doctors develop a plan called the clinical trial protocol. The plan is comprehensive which includes the reason for the study, number of people to be enrolled, eligibility of the participants, the drugs to be used, the necessary tests for evaluating the results and the needed information. These treatments are sponsored by organizations or individual looking for a better treatment.
These trials are supported at several organizations such as hospitals, universities, medical centers and private doctors’ offices. The researcher evaluates the efficacy of the new drug or treatment by comparing it with the standard treatment. This is achieved by creating two groups, the treatment group and the control group.
The treatment group receives the new treatment, while the control group receives the standard treatment. To disallow any bias, the participants are randomly assigned to the two groups. Further elimination of bias is achieved by single-blinded randomization in which the participants do not know which group are they a part of. Double-blinded randomization is when neither the doctor, nor the participants know which group they are a part of.
This helps in removing any doctor bias. Each trial study has its own specific eligibility requirements such as type, age, disease’s stage, age group, or history of the patients. To join a clinical trial, the prospective participant’s doctor must provide the trial investigator with details of the patients’ medical history.
Whether to participate in a clinical trial is a personal decision, but there are guidelines, which the patient may follow. Before taking any such decision, the patient must learn all about his or her disease and the nature of trial that he or she wants to partake. This should then be discussed with the doctor and the family members before determining about participation.
Benefits of Clinical Trials of Mesothelioma
The participants may benefit from the trials in several ways. They get the opportunity to be provided health care by some of the leading physicians in the field of cancer research. They get access to drugs that are more advanced than the ones available in standard treatment. They also get the opportunity to make a valuable contribution to the study of cancer research.
These benefits, however, come with some risks that the participant is also exposed to at the same time. The new drugs may have unknown side effects and may prove detrimental to health, even fatally so. The drugs may be less affective than the ones already being used by the patient. The drug may have been effective on one patient, but may be totally ineffective on the other patient. The effects of the drug are not uniform and unpredictable. Because of the risks, the patient is exposed to and the danger that a researcher may exploit a participant, they need to be protected.
All the government-funded clinical trials must have their trial protocols approved before they can begin. The law requires the researcher to completely inform the patient about the study’s treatments and tests, and their possible benefits and risks. This informed consent must be signed before the participant can take part in the trial.
Many other drug trials involve extensive use of placebos but such usage is largely absent from cancer’s clinical trials. The reason is that most of these trials are designed compare the new test with the standard treatment, which is believed to be the best available treatment for cancer based on past research. Cancer trials, therefore, are gradual improvement over previous treatments rather than development of a new drug altogether for a yet incurable disease.
The payment of the trials is made by government funding, institutional funding or health insurance. Some health insurance companies, though, may not cover these trials as they are considered “experimental” or “investigational”. It is always best to check with the insurance company or the National Cancer Institute to financial solutions.
Each trial consists of three distinct stages or phases. Each trial must complete the first two phases, and the third phase is carried out depending on the outcome of the second phase. The phases are as follows:
Phase I
This phase enrolls a small number of people after checking for their eligibility and tests how new drugs and procedures should be administered.
Phase II
This phase gives an early indication about the efficacy of the new drug and also gives information about the safety, befits and risks of the drug. The third phase is conducted based on results found in this phase.
Phase III
This phase compares the treatment group’s results with the control group’s results. In this phase, the number of participants is greatly increased and they are randomly assigned to either the treatment group or the control group.
After the completion of the first two phases, the findings of these stages are analyzed by the researchers. If the drug proves to be either ineffective or unsafe, the clinical trial is halted and the third phase is not carried out. If the drug proves to be both safe and affective, the third phase is carried out. After its completion, its results are analyzed for medical relevance. If the results are positive after the completion of the analysis, the results are submitted to the FDA for the approval. The FDA then reviews the results on its own and then approves or disapproves its manufacture by pharmaceutical companies. |
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