The development of new treatments for mesothelioma is a complicated, expensive, and time consuming process. This is made even more so by the risks inherent in trying “unproven” treatments. Mesothelioma clinical trials are not the beginning of the research process, but are often the last steps before a drug, procedure, or tool can be released to the medical community as safe to use.
Contact the Meso Foundation for more information on finding mesothelioma trials, and how you can participate.
Testing and Researching before Human Clinical Trials Begin
Researching and developing new drugs and procedures doesn’t involve human patients until a lot of work has already been done in the lab. In vitro (test tube) testing of drugs is followed by in vivo (in the body) tests using animal models to evaluate the treatment. Just as major surgical advances such as open heart surgery, heart, liver, kidney and lung transplants were first perfected on animals, so too are new drugs developed and tested, first in the lab and then on special animal models that mimic human systems. This is done to ensure that new treatments can be tolerated and have a measurable effect. None of these early steps are to be confused with clinical trials, and patients should never feel they are being “guinea pigs” by consenting to a clinical trial.
Three Phases of Mesothelioma Clinical Trials
Clearly, it is impossible to assure that new drugs or procedures are safe or will work in humans if they are never tried on volunteers under carefully controlled conditions. The purpose of each step of the clinical trial is to validate that a mesothelioma treatment is tolerable, that it has an effect worth pursuing, and that it is equal to or better than existing treatments. Roughly speaking, this represents the three phases of clinical trials that are open to patients.
- Phase one mesothelioma clinical trials are often called dose escalation trials because each group or cohort of patients in the study is given a higher dose than the last. This is done to establish an upper safe limit or threshold for the treatment and monitor for side-effects. There are usually at least three patients in a cohort to ensure that observed effects are repeatable and not reflective of one individual’s unusual biology.
- Phase two mesothelioma clinical trials are given to larger groups of patients to establish if the treatment has an effect and to further monitor for safety.
- Phase three mesothelioma clinical trials are given to an even larger group of patients to confirm the treatment’s effectiveness, monitor for side effects, compare it to existing mesothelioma treatments, and to collect information to allow the experimental drug or treatment to be used safely.
There is also a rarely discussed phase four clinical trial which is done after the release of a treatment. This is done to continue to monitor for effectiveness, refine the target population for the treatment, and to monitor for safety.
Not all clinical trials are for treatment purposes. There are trials for evaluating preventative measures, to assess diagnostic tools or techniques, to evaluate screening methods for cancer, and to assess quality of life protocols. For more information, contact the Meso Foundation.
