Mesothelioma Clinical Trial Phases

Clinical trials are conducted by researchers in steps called phases. Each phase or step answers certain questions. The Food and Drug Administration (FDA) allows the pharmaceutical manufacturers of a drug to sell their product only after it has been proven safe and effective in clinical trials. Clinical trials are usually classified into one of three phases:

Phase I - Evaluates how doctors should administer a new drug (that is, 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. After Phase I is completed, the researchers carefully examine the collected data and decide if they should move to Phase II or stop testing the drug because it has proven unsafe or ineffective.

Phase II - Gives early information about how well the new drug or procedures work and also provides information about the safety and benefit of the drug. Phase II trials usually narrow the focus to a particular type of cancer. After Phase II is completed, the researchers carefully examine the collected data and decide if they should move to Phase III or stop testing the drug because it has proven unsafe or ineffective.

Phase III - Tests a new drug, a new combination of drugs, or a new surgical procedure compared to the current standard treatment. Phase III trials often enroll large numbers of people from across the country and may be conducted at many doctors' offices, clinics, and cancer centers. When Phase III ends, the researchers analyze the data and determine if the results have medical relevance. When the analysis is complete and if the results are positive, the drug is submitted to the FDA for approval.