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Understanding risks & benefits of mesothelioma clinical trials

After receiving a mesothelioma diagnosis you might be considering treatment options available. For those interested in cutting edge and alternative treatment options, clinical trials might be a choice. Before signing up for a trial, it is important to understand the potential risks and benefits associated with clinical trials.

 

What is a clinical trial?

Clinical trials use human subjects to test new medicines and experimental treatment options in a structured and safe environment. The trials are a live setting way for scientists to test new technology, medicines or a combination of both. Clinical trials for mesothelioma patients test drug and other therapy approaches to see if certain therapy treatments are more effective than others. Trials can last for weeks, months or years depending on what is being tested. Often the trials are sponsored by a government agency, but pharmaceutical companies frequently fund clinical trials.

There are four different phases of clinical trials as the testing progresses. The first phase only has a few participants in order to test for safety. These are the riskiest trials. In phases II and III more subjects are used and things such as dosage calibration and side effects are measured while reviewing the overall treatment effectiveness compared to the standard approach. Phase IV occurs after the FDA has approved the new therapy and is required to ensure treatment effectiveness.

Trial advantages

The goal of clinical trials is to change the way cancer is treated. There are trials going on for different types of mesothelioma and in different geographic areas, so subjects can find one within traveling distance from their home. For mesothelioma, many of the drugs used on test subjects are already approved by the FDA and used to treat other forms of cancer. Research subjects are protected by institutional review boards. The different therapies used may improve the length and quality of subject life.

Generally the cost for clinical trial treatment is minimal. Often the trials are sponsored by a government agency, but pharmaceutical companies frequently fund clinical trials. Patients are typically responsible for paying for doctor visits, hospital stays, lab tests and x-rays. Depending on your health insurance plan, these costs might be covered by your provider. Some states even require health insurance providers to pay for routine care for people who are test subjects in clinical trials.

Associated risks

The major downside of clinical studies is that human subjects are at risk; the risk ranges from mild discomfort to serious pain and even death. While the risk is balanced against the possible potential benefits a subject might receive from the treatment, test subjects need to be clearly informed of all the risks associated with the proposed treatment.

Also, subjects assume that they are partaking in research that could yield scientific knowledge and improve treatment options for others with the same condition. As outlined in the Nuremburg Code, the “experiment should be such as to yield fruitful results for the good of society,” while “the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.”

Clinical trials have come under fire for supporting the goals of pharmaceutical giant’s commercial marketability rather than finding solutions. Ethically pharmaceutical companies have a duty to put the best interests of the subjects over the financial interests of the company. If you are considering participating in a clinical trial make sure to clearly understand what the trial entails and all of the potential risks.

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