The FDA requires several clinical trials before approving a new drug, a new therapy, or different combinations. This is precisely why Clinical Trials play a vital role in the discovery of new, advanced treatments for asbestos cancer, Mesothelioma. They allow mesothelioma patients to gain access to more advanced treatments such as immunotherapy and gene therapy.
Both gene therapy and immunotherapy have not yet been approved by the FDA, although they are considered as the future treatments for different types of cancers.
Many doctors believe that these advanced treatments present great opportunities for patients such as extending their lifespan, reducing pain and suffering, and improving their quality of life.
Clinical trials for mesothelioma can take weeks, months, years, or even decades depending on the set goal, and whether the new drug/therapy requires additional testing before getting accepted on the market. In other cases, some new drugs/therapies require more than one clinical trial so as to determine their effectiveness and efficacy.
Is it Necessary to Participate in Clinical Trials?
Enrollment in mesothelioma clinical trials is completely voluntary. The trial doctors will explain every single detail of the study to ensure that you are well informed before agreeing to take part. The process is known as giving your informed consent.
You’re free to back off the trial anytime you feel like and for any reason. No one will blame you or hold you accountable for anything. All the same, taking part in these trials gives you a much better chance of beating mesothelioma. Also, you are taking part in a very important course that may greatly benefit future patients by providing the doctors and researchers with highly valuable information and feedback.
If you are more than willing to participate in these trials, you will be happy to know that you can apply anytime you want since various centers are recruiting all the time.
Over 50 percent of mesothelioma patients take part in at least one clinical trial.
Clinical Trial Objectives
Just like with any other study, there are various objectives for carrying out clinical trials for mesothelioma. They include;
- To determine if the new treatment/therapy will work.
- To determine if the new treatment/therapy is likely to be helpful.
- To determine if the new treatment/therapy will work better compared to other available treatments.
- To check the side effects that may be caused by the new treatment/therapy.
- Do determine whether the benefits of the new treatment/therapy outweigh the risks, including the side effects.
- To determine in which patients the new treatment/therapy will most likely be effective/helpful.
Factors Considered for Clinical Trial Eligibility
Not every mesothelioma patient qualifies for a clinical trial. There are certain inclusion and exclusion criteria that either allow or disallow an individual from taking part in the trial. In other words, each clinical trial has specific eligibility requirements.
Eligibility for mesothelioma clinical trials may be determined by factors such as;
- Age and gender of the patient
- Stage of mesothelioma
- Treatment or therapy history
- Medical history
- Type of mesothelioma
- Current physical health/Overall health of the patient.
- Underlying medical conditions
Some clinical trials even seek patients who have undergone specific mesothelioma treatments or those who have not yet received any treatments.
However, a good number of all clinical trials require participating patients to be in good physical health. Some studies may exclude current or former smokers.
If you are willing to take part in the clinical trials, it’s highly advisable that you consult your doctor to confirm whether you are eligible or not.
Clinical Trial Phases
The U.S Food and Drug Administration (FDA) requires that all clinical trials be carried out in three different phases before receiving approval. Let’s have a look at the main clinical trial phases.
- Phase I: The Phase I clinical trial usually involves about 20 or more people who analyze the safety of the new drug or therapy. In this Phase, the main goal is usually to analyze any side effects that may be exhibited and also examine how the body processes the drug. The phase also evaluates the safe dosage levels.
- Phase II: This phase includes approximately 300 patients. It usually involves checking the effectiveness of the drug/treatment therapy and its safety levels. The drug/therapy may even be compared with a placebo or other treatment options.
- Phase III: This trial phase usually involves a larger group which comprises of several thousand people. In this phase, the effectiveness of the new treatment/therapy is measured and compared to the standard treatment methods. The phase also involves finalization of dosage amounts as well as documenting the side effects.
- Phase IV: The Phase IV trial is carried out after approval by the FDA. This phase usually involves the long-term testing of the effectiveness and safety of the new drug/treatment in a diverse population of patient.
Who Pays for Mesothelioma Clinical Trials?
In most clinical trials for mesothelioma, the patient pays for some of the expenses while the government takes up the rest. The patient may be required to pay for doctor visits, laboratory tests, scans and X-rays, and transportation. Most of these costs are fully covered by the insurance company, although some states require these companies to cover the routine care a patient receives in the clinical trials. The patient does not pay for any additional cost related to the clinical trials. These may include extra tests, research and analysis fees, and doctor and nurse fees.
While patients cover some of the expenses, government agencies or pharmaceutical companies typically absorb the majority of the costs.
The government also funds clinical trials for cancer research. A specific amount of money is set aside each year. Private donations also help cover the expenses of mesothelioma clinical trials.