Clinical Trials can provide the promise of new and more effective treatment options for those suffering from mesothelioma. These studies are typically focused on evaluating new and/or experimental treatments that doctors believe could be of benefit to patients with complex and hard to treat medical issues. Historically, clinical trials have proven to be of great benefit to many cancer patients.
The Food and Drug Administration (FDA) requires that a clinical trial complete three phases before any approval for the treatment can be granted.
Phase I Trial – Evaluates Safety
A Phase I clinical trial studies the best way to administer a new type of treatment and, if the study involves a new drug, how much can be given safely. In this phase, doctors monitor patients closely to see if they experience any harmful side effects. If determined to be "safe", the study of the new treatment will enter Phase II.
Phase II Trial – Evaluates Effectiveness
A Phase II clinical trial measures the effectiveness of a research treatment once it has been deemed safe in Phase I. The cancer sites in participating patients are closely monitored during this phase to evaluate whether or not the treatment has had any effect on these sites compared to what was present at the outset of the trial. Side effects are also monitored and evaluated. If the treatment is found to be effective in the smaller Phase II populations, the trial will go to Phase III.
Phase III Trial – Evaluates Safety and Effectiveness in Large Populations
Phase III trials evaluate the safety and effectiveness of a research treatment or drug on large numbers of patients. Often, Phase III trials can involves thousands of participants. In this phase, different groups are established. A clinical trial that is evaluating a new chemotherapy drug, for example, will establish one group called the control group. This group receives chemotherapy treatment that has already been tested and approved. Other groups are also established that receive a different type of treatment that may or may not contain the investigational chemotherapy drug. The purpose of this phase is to evaluate the effect that the new drug has on survival rate as compared to traditional drugs and to monitor side effects and other safety issues that may come up in the study. If the side effects are too severe, treatment is discontinued.
Researchers conduct studies of new treatments to answer the following questions:
- Will this new treatment be of benefit to patients?
- Is this new type of treatment effective?
- Is it more effective than other treatments already available?
- What are the side effects associated with this treatment?
- Considering side effects, do the benefits outweigh the risks?
- For which patients will this treatment be most helpful?
Participation in a clinical trial does involve some risk. Those involved do not know in advance whether the treatment will work or what the side effects will be. That is what the study is designed to discover. Although the majority of side effects will not be life-threatening, some can be. Bear in mind, however, that even approved treatments have side effects. Your doctor can help determine whether participation in a clinical trial is right for you.
If it is determined that participating in a clinical trial would be beneficial to you, your doctor will explain the study in detail and ask for your informed consent. You are never obligated to continue with a study, however. If, after providing your signed consent, you decide to leave the study you are free to do so at any point and for any reason. Taking part in the study does not prevent you from getting other medical care you may need.
Your cancer care team can provide you with more information about participating in a clinical trial. Some of the questions to consider are:
- What treatment or drug is this study evaluating?
- Are there specific kinds of tests and treatments that will be involved?
- What is the purpose of this treatment?
- If I do, or do not participate in this study, what is likely to happen to me?
- Do I have other options and what are their advantages and disadvantages?
- Will my daily life be impacted?
- What are the expected side effects? Can they be controlled?
- Will my participation involve hospitalization? If so, how often and for how long?
- Is there any cost associated with the study or the treatment?
- What treatment am I entitled to If I am harmed as a result of the research?
- Does the study require any long-term follow-up care?
- Has the treatment been used to treat other types of cancers?
Active Clinical Trials
ClinicalTrials.gov provides a wealth of information about federally and privately sponsored clinical trials that are currently being conducted in the United States and 173 other countries around the world. The site was created by the U.S. National Institutes of Health in collaboration with all NIH Institutes and the Food and Drug Administration following the Food and Drug Administration Modernization Act of 1997.
ClinicalTrials.gov provides clinical trial information for a wide range of diseases including mesothelioma. The site provides comprehensive data on each trial's objective, whether or not it is recruiting participants, progress updates, locations, contact information and more.