Mesothelioma clinical trials are typically conducted in a series of steps, or phases. Each mesothelioma clinical trial phase answers specific questions about the mesothelioma treatment being studied.

Investigational New Drug Application (IND)

If the purpose of a mesothelioma clinical trial is to study the effects of a new drug, researchers must first create a plan of action or protocol. An IND is an application that is presented to the FDA, containing vital information about the treatment as well as lab and animal test data. If the IND is approved by the FDA, mesothelioma clinical trials are allowed to begin.

Phase I

In the first mesothelioma clinical trial phase, researchers determine the best way to administer the mesothelioma drug in humans. Questions to ask during this phase are, "What is the proper dose? Frequency? Should the treatment be taken by mouth or injection?" Researchers also watch for any harmful side effects that occur. Since little is known about the treatment at this stage, Phase I studies usually involve small groups of patients.

Phase II

In Phase II, researchers study the safety and effectiveness of a mesothelioma medication or treatment, and evaluate its effect on the human body. For example, researchers may ask, "Does this treatment shrink a tumor or effectively destroy cancer cells?" Because of the potential risks involved, the studies of this mesothelioma clinical trial phase usually include fewer than 100 patients.

Phase III

In this phase, researchers compare a new mesothelioma medication or treatment with the current standard therapy. They may ask, "Which treatment has better survival rates? Which has fewer side effects?" Computers randomly assign participants to groups, with each group receiving either the current standard therapy, the trial therapy or, in some cases, a placebo. This mesothelioma clinical trial phase often involve hundreds of patients in various locations across the country.

Phase IV

In Phase IV, researchers continue to explore and evaluate the long-term safety and effectiveness of a new mesothelioma treatment, typically after the treatment has been approved for standard use. Phase IV studies, also known as postmarketing surveillance studies, usually involve hundreds or even thousands of patients.

FDA Approval

Typically, once Phases I and II are successfully carried out, the sponsor of a mesothelioma clinical trial submits a New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA). The application requests permission to begin Phase III trials with the expectation that the drug will show sufficient benefits to warrant approval for public use.

Every product that is proposed for mesothelioma treatment must be reviewed by a committee of leading oncologists from around the country. To be approved by the FDA, a mesothelioma treatment must be shown to provide valuable benefits in both safety and effectiveness compared to standard treatment methods. Once a product is approved for a particular disease, it may be used freely by physicians, but only in the treatment of that condition.