Clinical Trials and Experimental Therapy

Clinical trials are studies involving treatments that are in the experimental and research stage of development. Participants are administered the cutting-edge treatment and their reactions are examined to better understand and measure effectiveness. The treatment may be a new drug, new technology or combination of both.

You may be asked to participate in a clinical trial if your doctor believes it would be of benefit to you and haven’t responded well to conventional treatments, like surgery, radiation therapy and chemotherapy. As a study participant, you may be able to have your insurance cover related costs. However, it is typical that the majority of costs are covered by the company or university conducting the clinical trial or the involved government agencies.

Clinical trial phases

There are three categories that clinical trials are divided into: prevention, screening and treatment. Whatever the category, each is further divided into four phases.

Phase 1: This is for a small group of participants to analyze safety by examining how the treatment is processed by the body, what a safe dosage level is, and what the side effects are.

Phase 2: This is for up to 300 participants and essentially does the same as phase 1, but with closer inspection. It may also be comparative, noting how the treatment does against another one or placebo.

Phase 3: Up to a thousand participants are observed in this phase, and the treatment is compared to standard approaches. Dosage amounts are finalized and side effects are detailed.

Phase 4: This often occurs after FDA approval for standard use. Effectiveness and safety is examined in a diverse participant population for the long-term.

A treatment must be deemed effective after the first three phases before it can be considered by the FDA for approval.

How to find out more about clinical trials

While your doctor would be the best source to ask in finding out what clinical trials exist, you can also visit ClinicalTrials.Gov. Developed by the US National Institutes of Health in collaboration with the FDA, this website lists all registered clinical trials for mesothelioma and other diseases that have been privately or federally sponsored in the US as well as a number of countries around the world. Each listing details the objective of the trial, contact information and if it is currently seeking participants or not (their status will be labeled as “recruiting” or “not recruiting”).

Examples of clinical trials: immunotherapy and gene therapy

Immunotherapy can reduce the severity of symptoms and lengthen life expectancy. The treatment enhances your immune system, making it stronger to fight against mesothelioma. This is done by either stimulating your immune system or enhancing it with man-made components.

Gene therapy manipulates your genes, fixing or destroying mutated ones and replacing them with new ones that help improve your condition. While promising, this treatment is still relatively new for mesothelioma patients and is more palliative rather than curative.

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