Drug Related Clinical Trials

Malignant mesothelioma has thus far proven to be an incurable disease. Linked exclusively with asbestos exposure, malignant mesothelioma is a relatively rare type of cancer that affects the serous tissue lining the body's three largest cavities: the pleura (lung cavity), the peritoneum (abdominal cavity) and the pericardium (heart sac).

With no viable treatment modality in place through which to combat malignant mesothelioma, attention has turned to the research and development of new modalities with the hope that they might succeed where current efforts are failing. There are 2,000 to 3,000 new cases of mesothelioma diagnosed each year in the United States alone.  At this time survival rates for mesothelioma are very poor.

Clinical trials are research studies used in medicine to test the safety and efficacy of a newly development treatment. More often than not, clinical trials are associated with the testing of a new drug; however, clinical trials are used to test any new treatment modality, including newly developed surgical methods, gene therapies, radiation treatments, etc.

Drugs and Clinical Trials

The majority of clinical trial research revolves around the testing of a newly developed drug. Drugs are regulated by the Food and Drug Administration (FDA) and must be approved by that government agency before they may be marketed to patients.

Drug clinical trials consist of four phases:

Phase I: the first phase involves testing the newly developed drug in the treatment of a small group of people, while simultaneously measuring its safety, dosage range and any side effects.

Phase II: the second phase of any clinical trial involves testing the drug on a larger group of people.

Phase III: the third phase of any clinical trial involves comparing the drug to commonly used treatments in order to determine its effectiveness versus that of standard treatment modalities.

Phase IV: the fourth and final phase of any clinical trial follows FDA approval. The drug is branded and marketed for distribution. Long-term studies monitor any latent side effects.

Non-Drug Related Clinical Trials

Non-drug related clinical trials are much the same as drug clinical trials with the exception that they do not always require FDA approval. Whereas drug clinical trials consist of four phases, non-drug related clinical trials typically consist of three.

Although the FDA does not regulate the development of new treatment modalities, it does regulate any newly developed medical devices used in the practice of such treatments. For example, the development of a new surgical procedure aimed at curing malignant mesothelioma is not regulated by the FDA; however, a newly developed surgical tool used to perform the surgery does require FDA approval. The FDA approves the safety and efficacy of the device as opposed to the safety and efficacy of the treatment.

Mesothelioma Treatment Overview

Malignant mesothelioma is a disease that can take anywhere from 30-to 40-years to become symptomatic and fully developed. Once diagnosed, a given case of mesothelioma cancer has typically reached a advanced stage, yielding an average post-diagnostic survival time of between one and two years.

There are a number of mesothelioma treatments used to combat the aggressive asbestos cancer, some of which include traditional methods like surgery, chemotherapy and radiation therapy; and newly developed modalities including photodynamic therapy, gene therapy and intensity modulated radiation therapy. Unfortunately, none of the aforementioned treatments have been successful in eradicating the disease.  Life extension is the main goal of current clinical trials.