To learn whether promising new or experimental treatments for any medical condition are actually beneficial, physicians conduct studies that are called clinical trials. When a patient is diagnosed with mesothelioma, the doctor may recommend participation in a clinical trial that is testing the success rate of a new treatment. Clinical trials are performed only when it is believed that that the treatment under review may help the patient. Often, the treatments given in clinical trials are found to have real benefits.
A treatment must undergo three phases of clinical trial before the U.S. Food and Drug Administration will approve it:
The Phase I trial is conducted on a limited number of patients to learn how to administer a new treatment and to make sure of the proper dosage. Doctors closely monitor patients for any harmful side effects. At this stage, the proposed new treatment will have been well tested in laboratory research and animal studies, but possible side effects in patients are not always known.
The Phase II trial begins after the safety of the treatment has been established in a Phase I trial. In Phase II, physicians closely observe patients to determine how their cancer responds to the treatment. Doctors take detailed measurements of the cancer site before and after the treatment, and then compare the measurements to determine the effectiveness of the treatment being studied. In addition to studying the beneficial aspects of the treatment, researchers also record and assess any side effects.
Phase III clinical trials are opened up to a large number of patients to compare the benefits of the new treatment to the success rate of existing therapies. One group generally receives the standard, traditional treatment; these patients are called the “control group.” Another group of patients receives the new treatment. A comparison of the results will allow scientists to determine whether the new treatment is actually better for some patients than the standard treatment. Doctors closely monitor all patients in Phase III trials for side effects, and discontinue treatment if the side effects are too severe.
Clinical trials are used by scientists to learn a number of things: whether the treatment is likely to help; whether the new treatment works better than the therapies already available; what side effects are caused by the new treatment; whether the benefits outweigh the side effects; and which types of patients are most likely to benefit from the new treatment.
Although new treatments offer great promise, they also carry some risk. It is unknown how well the treatment will work or what side effects it will cause. While most side effects go away after a short period of time, some are severe and may even be permanent. For this reason, patients should discuss the matter at length with their doctors. The patient’s team of doctors and nurses will explain the clinical trial in detail. To participate, the patient must read and sign a form expressing the desire to participate in the study; this is called informed consent. Still, patients can choose to leave a clinical trial at any time for any reason.
When thinking about participation in a clinical trial, a number of factors should be considered and discussed with the patient’s medical team. These factors include:
- Purpose of the study
- Tests and treatments required
- How the treatment works
- What is likely to happen with, or without, the experimental treatment
- Advantages and disadvantages of other available treatments
- If the study will affect the patient’s daily life
- Expected side effects and means to control them
- Whether hospitalization will be required, and if so, how much
- Any cost of the clinical trial to the patient
- Whether medical care is available should there harmful effects from the treatment
- If long-term follow-up care is provided
- Whether the treatment has been used for treating other types of cancers
A patient’s physician is always a good resource for finding clinical trials studying the treatment of mesothelioma. Another source is the National Cancer Institute of the U.S. National Institutes of Health, available by phone, 1-800-4-CANCER, or on the Internet, http://www.cancer.gov/search/ResultsClinicalTrials.aspx?protocolsearchid=6678008.