What Are Clinical Trials?
In addition to the standard multimodal treatment plan for mesothelioma, which usually involves a combination of surgery, chemotherapy, radiation, targeted therapy, and immunotherapy, researchers are constantly exploring new ways of extending and improving the lives of patients with mesothelioma or other asbestos-related diseases through clinical trials.
Before these new diagnostic and treatment options can be offered to the public, they must undergo clinical trials. Clinical trials are experimental studies conducted with groups of patient volunteers. The goal of these studies is to determine if the new procedure or treatment is safe and effective for humans. There is usually a strict inclusion and exclusion criteria that each individual patient needs to meet in order to be part of the clinical trial.
Clinical trials are conducted in a variety of settings, including hospitals, doctors’ offices, community clinics, and universities. The location depends on who is conducting the study and some trials may be offered at multiple, different locations. Every clinical trial is led by a principal investigator (often a medical doctor). They usually also include a team of additional doctors, nurses, and other health care professionals.
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Phases of Clinical Trials
For new drugs, there are typically three phases of clinical trials before they can be approved by the Food and Drug Administration. These are sometimes followed by a fourth phase that occurs after the initial FDA approval to monitor the side effects and effectiveness of these therapies.
- Phase 1 clinical trials determine safety, tolerability, and dosage. These trials are conducted with a small group of people and look at safe dosage levels and how the body metabolizes the drug. Phase 1 clinical trials usually last several months.
- Phase 2 clinical trials determine effectiveness and side effects. These trials are conducted with a larger group of people and aim to determine the effectiveness of certain dosages to achieve the desired effect (pain relief, tumor shrinkage, etc.). They also examine any side effects. Phase 2 clinical trials can last several months or a couple of years.
- Phase 3 clinical trials compare the new treatment to existing treatments and/or placebos. These trials are conducted with a large group of people and aim to determine whether the new drug is more effective than existing drugs. They are also used to discover any previously undetected side effects or adverse reactions. Phase 3 clinical trials can last several years.
- Phase 4 clinical trials study long-term uses and reactions to approved drugs. These trials are conducted with a large group of people who are already using the new drug and aim to uncover any long-term side effects or adverse reactions to drugs, as well as prove out their long-term effectiveness as a treatment. Phase 4 clinical trials can last years.
Clinical Trials for Mesothelioma Patients
There are dozens of current and upcoming clinical trials available to mesothelioma patients across the United States. Visit ClinicalTrials.gov to find the most up-to-date list of mesothelioma clinical trials and speak with your doctor to find out which qualifying trials may be the right course of treatment for you.
It’s important to note that not every mesothelioma patient may be eligible to participate in a particular clinical trial. Each study has its own standards determining who can participate. Some clinical trials are only open to participants who have the disease that will be studied, while others may instead be looking for healthy participants. Still, other trials are limited to a specific group of people who are invited by the investigators to participate. Finally, many trials will include or exclude participants based on factors such as age, gender, race or ethnicity, the type of mesothelioma present (pleural, peritoneal, or pericardial), the stage of the disease (1–4), the cell type present in the tumor (epithelioid, sarcomatoid, or biphasic), certain biomarkers, previous treatment history, or other medical conditions.
Are Clinical Trials Safe?
Clinical trials do involve a certain amount of risk — these are, after all, the first tests of new drugs on human subjects. However, all federally funded or conducted clinical trials are reviewed, approved, and monitored by an institutional review board, or IRB. These boards are made up of doctors, researchers, and members of the community. Their role is to ensure that the clinical trial is conducted in an ethical manner and that the rights and well-being of participants are protected. This includes making sure that the risk to participants is minimized.
Some clinical trials are also monitored by data monitoring committees, or data safety and monitoring boards. In addition, various government agencies — including the Office of Human Subjects Research Protection and the Food and Drug Administration (FDA) — have the authority to oversee that clinical trial participants are adequately protected.
If you decide you’d like to participate in a clinical trial, the lead researcher will explain the details about the trial and have you complete a form indicating your desire to join. This is called informed consent, and it’s intended to protect participants. The researcher should provide enough information for you to understand the risks, potential benefits, and alternatives to the clinical trial. However, signing an informed consent document is not a contract. Clinical trial participants may withdraw at any time, even if the trial is not over.
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Questions to Ask Before Consenting to a Clinical Trial
You should always feel free to ask questions before, during, and after the clinical trial, regardless of whether you have already signed the consent form. Here is a list of questions provided by the National Institutes of Health (NIH) that you may want to ask before deciding to participate in a clinical trial for mesothelioma:
- What is being studied?
- Has the treatment been tested before?
- Why do researchers believe the treatment being tested might be effective? Why might it not be effective?
- What are the possible treatments that I might receive during the trial?
- How will it be determined which treatments I receive (for example, by chance)?
- Who will know which treatment I receive during the trial? Will I know? Will members of the research team know?
- What will I have to do?
- How long will the clinal trial last?
- What tests and procedures are involved?
- How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
- How often will I have to visit the hospital or clinic?
- Will hospitalization be required?
- Who will pay for my participation?
- Will I be reimbursed for other expenses, such as travel and accommodations?
- If I benefit from the treatment, will I be allowed to continue receiving it after the trial ends?
- Who will oversee my medical care while I am participating in the trial?
- What type of long-term follow-up care is part of this trial?
- Will the results of the study be provided to me?
- What are my options if I am injured during the study?
Despite the potential risks, clinical trials can be extremely beneficial, especially for mesothelioma patients who haven’t responded favorably to conventional mesothelioma treatments and medications. Clinical trials can also lead to major breakthroughs in diagnostic procedures and emerging treatments for mesothelioma patients in the future.
What If I’m Not Eligible for a Clinical Trial?
Although drugs that are not yet approved by the FDA are usually only available to clinical trial participants, there are some exceptions. Compassionate drug use is the use of new, unapproved medications to treat seriously ill patients when no other treatments are available. These patients may live too far from available clinical trial locations, or they may not eligible. Talk with your mesothelioma specialist about whether compassionate use might be an option for you.
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