Clinical trials are studies of new treatments in patients. Researchers perform a clinical trial only when there is some reason to believe that the treatment in question may help patients. In general researchers perform clinical trials to determine whether a treatment works, whether it is more effective then existing treatments, whether the side effects are too severe to justify the treatments use, and which patients benefit most from the treatment. Currently, there are sixteen active clinical trials throughout the world investigating new therapies for mesothelioma. Researchers are conducting eleven of those trials in the United States.
During the course of treatment, a doctor may suggest that a patient look into a clinical trial. Though this does not mean that the patient has no other hope, the patient should be aware of the risks associated with clinical trials. No one knows in advance if the treatment will work or exactly what side effects will occur.
Researchers conduct clinical trials in steps called phases. Each phase answers certain questions. Clinical trials are usually classified into one of three phases. Phase I trials evaluate how doctors should administer a new drug (i.e. by mouth, injected into the blood, or injected into the muscle), how often, and at what dose. A Phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen. Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works. Phase II studies usually narrow the focus to a particular type of cancer. Phase III trials test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. Researchers assign participants to the standard group or the new group at random. Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
The benefit of participating in a clinical trial is that a patient can receive a treatment that the U.S. Food and Drug Administration has yet to approve. In the case of promising drugs, this may improve the patient chance of survival.