Clinical Trials - Overview
Clinical trials are a potential option to consider when deciding upon your mesothelioma treatment plan. These trials are new and/or experimental patient treatment plans that show promise but are not part of the mainstream medical treatment options. Only patients believed to receive benefit from a clinical trial are typically accepted.
Each clinical trial works to find better ways to treat, diagnose, screen and monitor diseases, such as mesothelioma, through research and testing. These trials are sponsored by various groups and agencies including:
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
- Department of Defense
- Department of Veterans Affairs
- Pharmaceutical companies
- Medical institutions
The National Institutes of Health (NIH) exclusively performs clinical trials. They do not perform routine medical procedures like other medical facilities. Admission is determined by the staff physicians and is only applied to those who meet strict criteria, including having an illness that is presently being researched via clinical study. For more information on the types of trials and admission information, see the NIH Fact Sheet.
The NCI sponsors many clinical trials and makes them widely available in the United States. These include:
- The Cancer Centers Program – supports research-oriented institutions
- The Specialized Programs of Research Excellence (SPOREs) – brings scientists and researchers together to design and implement research programs
- The Clinical Trials Cooperative Group Program – builds cooperative groups of researchers, cancer centers and doctors to identify questions in cancer research and conduct clinical trials.
- The Cancer Trials Support Unit (CTSU) – allows for NCI phase III trials to be made available to doctors in the United States and Canada.
- The Community Clinical Oncology Program (CCOP) – clinical trials are made available to a large number of communities across the United States.
- The National Institutes of Health Clinical Center – a research hospital in Bethesda, Maryland that is part of the NIH.
Each clinical trial has specific criteria that must be met for a patient to be accepted. Each trial must have three phases to be accepted by the Food and Drug Administration. As with any treatment for mesothelioma, it is important to get an early diagnosis and consult with your physicians to make the best decision for your ongoing treatment and care.
Clinical Trial Phases
There are three phases of clinical trials that must be studied before the Food and Drug Administration (FDA) will approve it for use.
- Phase I – to find the most effective means to administer a new treatment, including the appropriate amount. Teams administering new drugs and treatments watch carefully for any side effects since human testing begins during Phase I.
- Phase II - the studies are to determine if the drug works. Patients are administered the highest dose that can be safely given based on the information from Phase I.
- Phase III – this is the largest phase, typically involving hundreds of people. In this phase a control group receives a more widely accepted treatment while a second group receives the new treatment. These groups are carefully watched for side effects. If one group shows significant improvement over the other, or if side effects of the new treatments are too severe, the study is stopped.
There are also different types of clinical trials. These include:
- Prevention trials which test new approaches that doctors believe may lower the risk of developing a certain cancer. These are typically conducted on healthy individuals with no cancer, or those who have had cancer previously but show no signs.
- Screening trials study detection methods in an attempt to detect cancer earlier. They focus on finding cancer before it causes symptoms to determine if this early detection will decrease the chance of dying. These trials are conducted on people who do not have any cancer symptoms.
- Diagnostic trials study processes that could potentially be used to more accurately identify cancer. These trials are conducted on people who have signs or symptoms of cancer.
- Treatment trials are designed to answer specific questions and evaluate the effectiveness of a new treatment or new way of using a standard treatment. These trials are conducted on people who have cancer.
If you are accepted to a clinical trial for mesothelioma, you have a team of experts closely monitoring your progress. However, there are risks since no one knows the outcome of the new treatment. Only you can decide if a clinical trial is best for you.