Mesothelioma Clinical Trials

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Mesothelioma Clinical Trials
Mesothelioma Applied Research Foundation, Inc

Understanding Clinical Trials
Participating in a clinical trial gives a patient a chance to participate at the cutting edge of medicine and gain access to novel therapies, new chemical weapons, and advanced techniques not yet available to everyone. The development of new treatments for illness is a complicated, expensive, and time consuming process. This is made even more so by the risks inherent in trying "unproven" treatments. Clinical trials are not the beginning of the research process, but are often the last steps before a drug, procedure, or tool can be released to the medical community as safe to use.

Research into new drugs and procedures doesn't involve human patients until a lot of work has already been done in the lab. In vitro (test tube) testing of drugs is followed by in vivo (in the body) tests using animal models to evaluate the treatment. Just as major surgical advances such as open heart surgery, heart, liver, kidney and lung transplants were first perfected on animals, so too are new drugs developed and tested, first in the lab and then on special animal models that mimic human systems. This is done to ensure that new treatments can be tolerated and have a measurable effect. None of these early steps are to be confused with clinical trials, and patients should never feel they are being "guinea pigs" by consenting to a clinical trial.

Clearly, it is impossible to assure that new drugs or procedures are safe or will work in humans if they are never tried on volunteers under carefully controlled conditions. The purpose of each step of the clinical trial is to validate that a treatment is tolerable, that it has an effect worth pursuing, and that it is equal to or better than existing treatments. Roughly speaking, this represents the three phases of clinical trials that are open to patients.

Phase one trials are often called dose escalation trials because each group or cohort of patients in the study is given a higher dose than the last. This is done to establish an upper safe limit or threshold for the treatment and monitor for side-effects. There are usually at least three patients in a cohort to ensure that observed effects are repeatable and not reflective of one individual's unusual biology.

Phase two trials are given to larger groups of patients to establish if the treatment has an effect and to further monitor for safety.

Phase three trials are given to an even larger group of patients to confirm the treatment's effectiveness, monitor for side effects, compare it to existing treatments, and to collect information to allow the experimental drug or treatment to be used safely

There is also a rarely discussed phase four clinical trial which is done after the release of a treatment. This is done to continue to monitor for effectiveness, refine the target population for the treatment, and to monitor for safety.

Not all clinical trials are for treatment purposes. There are trials for evaluating preventative measures, to assess diagnostic tools or techniques, to evaluate screening methods for cancer, and to assess quality of life protocols.

Benefits of Clinical Trials
While there is no question that without clinical trials the development of new procedures and medicines would come to a virtual standstill, that may not be of much concern to a newly diagnosed mesothelioma patient facing a prognosis of a short median survival time. It is true that clinical trials are somewhat altruistic, i.e. they benefit your fellow man, the next victim of mesothelioma, but this shouldn't be the primary motivation for participating in trials. With almost no "standard" treatments for mesothelioma in the medical kit bag, clinical trials are the most effective and sometimes the only way a new patient can access state-of-the-art treatments.

Hopefully in ten or twenty years, many of the effective clinical trials of today will have become standard therapy. Clinical trials in that setting may not be as appealing to mesothelioma patients who have valid treatment options that offer a chance for a cure. However, as in many cancers, patients will always come along who won't respond to current treatments, were diagnosed at late stage, or who want less aggressive treatment than some of the surgery being performed today. For those patients a clinical trial will always be an attractive choice.

Choosing a clinical trial is a personal decision that should be made with the advice and counsel of your doctor and your family. Clinical trials have saved many lives and are currently the reason there is a growing population of mesothelioma survivors to point to. Before making the decision it is wise to ask questions and to fully understand the risks before signing the informed consent form. A clinical trial shouldn't be entered into lightly. Here are some questions to consider:

What is the purpose of the trial?
What tests and treatments will be used?
What is the track record, if any, of the experimental treatment?
What are the benefits, risks and side-effects in contrast to other treatment choices?
What steps will be taken to monitor safety and who will be responsible for actions in the event of a problem?
How long will the trial take and how long will I need to participate?

Can I opt out of the trial and under what conditions?
Who will conduct the trial and what are their credentials?
What portion of the trial is subsidized and by whom?

What portion of my treatment will my insurance cover and how much will I be responsible for?

Risks Of Clinical Trials:
Regardless of phase, all clinical trials entail some risks to the patient. The primary risk is that the treatment may not work and the patient may continue to get worse. In addition, because trials are offered in limited settings, being in a trial may involve additional time, travel, expense and effort on the part of the patient. Since one of the primary objectives of a clinical trial is to establish the safety of the treatment, it stands to reason that some participants may experience side effects that could range from being uncomfortable to being life-threatening.

Despite the experimental nature of clinical trials, the institutions that offer them are committed to minimizing the above risk as much as possible. The goal, after all, is to find a treatment that will help the patients, not harm them. This process is aided by the requirement that clinical trials must be approved by an Institutional Review Board (IRB). This is usually composed of researchers, institutional management and community members who evaluate the protocol or study plan for safety. Clinical trials must adhere to the same legal and ethical standards that apply to general medical practices. In addition, most American clinical trials are registered with and regulated by the United States government to ensure consistency and enforcement of standards. Our registry of clinical trials is linked to the National Cancer Institute's list of mesothelioma trials.

Primary Sources:
Mesothelioma clinical trials registered at the National Institute of Health (NIH)

Mesothelioma clinical trials registered at the National Cancer Institute (NCI)

A listing, with some duplication of clinical trials but with an emphasis on international trials at Center Watch.

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