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What is a clinical trial? A clinical trial is the term for research studies that aim to evaluate new ways of treating disease. Drugs that have shown promise in the laboratory, surgical procedures that have worked well in animal studies, and newly developed devices all need to be tested on human beings to be sure that they are both safe and effective. By the time a drug or procedure reaches clinical trial status, it has already been tested extensively, and has demonstrated a potential to be useful for the disease. Before the US Food and Drug Administration (FDA) will permit a drug or procedure to be marketed, it must be tested extensively with human volunteers.
What kind of clinical trials are there for mesothelioma? The largest group of trials is called treatment trials, and they are set up to answer questions about a proposed new treatment, or a modification of a current treatment. A treatment trial may test a new drug, or a combination of existing drugs that has not been previously tried. Treatment trials may also test the effectiveness of a new surgery, or a different approach to radiation.
The other kind of trial is for supportive care, in which drugs or procedures aimed at reducing the painful symptoms of the disease, or the side effects of mesothelioma therapy, such as sleep disorders, depression, nausea and vomiting, and fatigue.
How can I benefit from taking part in a trial? Trials are dealing with cutting-edge therapies, and the latest developments in treatment. As a participant, you have the opportunity to try the latest development, which may not be available anywhere else, and learn whether it will be helpful to you. Most trials also offer participants medical care related to their illness for free. The researchers involved have the most current knowledge of mesothelioma treatment, and trials are usually run out of major research institutions and medical facilities. You will also have the satisfaction of knowing that you're contribution to the understanding of your disease.
What are the risks and downsides of being in a trial? A trial frequently compares two treatment approaches, for example, the effectiveness of a new drug versus the effectiveness of a known drug. Study participants are usually assigned at random to one treatment group or the other, and cannot choose which they receive. The new drug or procedure may include risks and side effects. Researchers conducting the study will thoroughly explain the risks, but there can be surprises. Treatment outcome with the new procedure or drug may not be as good as with conventional treatment. As part of the study you may have to have additional tests or procedures.
Who can be in a clinical trial? A trial is designed to answer very specific questions about a new treatment, and often researchers are looking for people who are in a particular stage in the course of their disease. A trial may only accept participants who meet certain age or health status criteria, to be sure that they can tolerate the treatment. Listings of clinical trials always state the eligibility criteria.
Where do I find out about clinical trials? http://www.clinicaltrials.gov/ is the National Cancer Institute's listing of all trials, both federally and privately funded.
How should I decide whether to enter a clinical trial?
It's a highly person decision, and will vary from one individual to another. If you have mesothelioma and you're thinking about joining a trial, be sure to discuss your decision with your loved ones, and also with your healthcare provider. At http://www.cancer.gov/clinicaltrials/learning the National Cancer Institute offers a very thorough list of questions you may want to ask before joining a trial.
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