Clinical Trials (definition of)

Clinical trials are the procedures by which new drugs (like Gemcitabine, Navelbine, and Alimta®), therapies, and techniques for the treatment of diseases, like mesothelioma, are tested. Before a new drug is subjected to clinical trials, there must be some preliminary indications that a particular drug or technique will be effective and safe. Most clinical trials are funded by the pharmaceutical industry using U.S. government funds, but many of these are funded and operated by cancer centers, clinics, research hospitals, or foundations dedicated to a specific disease like peritoneal mesothelioma. Under the profit-driven corporate model of "health care," this is necessary as less "profitable" diseases receive very little study or attention.

Clinical trials are regulated by the Food and Drug Administration, which determines the requirements for procedures and participation. When it comes to serious, potentially terminal conditions, competition for spots in a clinical trial is fierce. Even then, there is no guarantee that a patient will not wind up being part of a "control" group that receives a placebo rather than the actual treatment.

Once the trials have been completed, the results are published in a medical journal and/or used as data for the FDA application that will determine whether or not the drug reaches the market.

There are risks to participating in a clinical trial. The condition may not respond to the treatment, or it may become worse; there may also be unforeseen side effects. For patients with a terminal prognosis however, this is usually not an issue.

For more information about clinical trials, please view our mesothelioma treatment guide.