What Are Clinical Trials?
Before it approves any new medication or cancer therapy, the Food and Drug Administration (FDA) requires a series of clinical trials to determine if the new treatment is safe and effective for humans. Clinical trials take place in a variety of settings, including universities, hospitals, doctors’ offices, or community clinics. Each study includes a principal investigator, usually a medical doctor, who leads the trial and a team of additional doctors, nurses, and health care experts.
Phases of Clinical Trials
New mesothelioma treatments usually require three phases of testing before receiving FDA approval. In some cases, new drugs or procedures undergo the fourth phase.
Phase 1 clinical trials last several months and are used to determine safe dosage levels. These studies involve a small group of patients, who are carefully watched so researchers can see how the body metabolizes the drug.
Phase 2 clinical trials last from several months up to two years. These studies involve a larger group of people who are given different amounts of the drug. This allows researchers to determine the necessary dosage for the desired effect, for example, pain relief or tumor shrinkage.
Phase 3 clinical trials last from one to four years and measure the new treatment against existing treatments or placebos. Researchers recruit a large group of people to help determine whether a particular procedure or drug is more effective than existing treatments. Phase 3 trials are also used to target any previously undetected adverse reactions or side effects in patients.
Phase 4 clinical trials don’t have a set time limit and can last for years. Researchers use this study stage to observe long-term use, efficacy, and reactions to drugs that are already approved.
Clinical Trials for Mesothelioma
Although mesothelioma is a rare disease, there are dozens of current and future clinical trials available to patients across the United States.
For an up-to-date list, patients may visit www.clinicaltrials.gov. Before enrolling, it’s best to check with an oncologist to determine which qualifying trials are right for your specific type of mesothelioma.
Not every patient is eligible to participate in a clinical trial. Studies have different standards to determine who can participate. Some experiments focus on healthy participants, while others are open to patients who already have the disease. In some instances, a principal investigator may invite specific patients to take part.
Trials may include or exclude patients based on mitigating factors, including:
- Race or ethnicity
- Type of mesothelioma
- Stage of cancer
- Tumor cell type
- Previous treatment history
- Other medical conditions
Are Clinical Trials Safe?
Clinical trials test new drugs and treatments on human patients, and they do involve a certain amount of risk. However, an institutional review board (IRB) exists to review, approve, and monitor all federally funded or conducted clinical trials. IRBs consist of doctors, researchers, and community members who have experience with the disease in question. Members of the board are there to ensure the trial is conducted safely and ethically to protect the rights and health of patients, and minimize any unnecessary risk.
Specific data monitoring committees and various government agencies, including the FDA and the Office of Human Subjects Research Protections, also review clinical trials. These boards oversee and protect all participants.
Patients who wish to participate in a clinical trial must meet or speak with the lead researcher, who will explain the trial process. They will also sign a document, called “informed consent,” that indicates their desire to join the study. The form is designed to protect patients. Researchers will provide detailed information about the trial, potential risks, and benefits, as well as treatment alternatives. Signing an informed consent is not a contract and clinical trial participants may withdraw at any time.
Questions Patients Should Ask Before Participating in a Clinical Trial
Patients may ask questions at any time before, during, or after the clinical trial. Below, there is a list of questions from the National Institutes of Health (NIH):
- What drug or treatment does this trial study?
- Has this treatment been tested previously?
- Why will this particular be effective? Why might it not be effective?
- What treatments will I receive during this trial?
- Who determines which treatments I receive?
- Will I know which treatment I receive?
- What will I need to do?
- How long will this clinical trial last?
- What type of test and procedures are involved in this study?
- Considering the possible risks, benefits, and side effects, how does this trial compare to my current treatment?
- How often should I plan to visit the clinic or hospital?
- Who pays for me to participate?
- Are travel expenses or accommodations reimbursed?
- If the treatment is effective, may I continue using it after the trial is complete?
- Who oversees participant medical care during the trial?
- Is there an option for long-term follow-up care?
- Do I have access to the results?
- If I am injured, what are my options?
- What are my options if I am injured during the study?
Although there are risks, mesothelioma patients may find clinical trials extremely beneficial, especially if their cancer hasn’t responded well to more conventional therapies. These studies may also lead to significant breakthroughs in treatment options or diagnostic procedures for future patients.
Are there any options if I’m not eligible for a clinical trial?
Drugs that are not FDA-approved are usually only available to people who have elected to participate in clinical trials, but there are some exceptions. Compassionate drug use is an option for patients who may live too far away from a clinical trial location, or if some other factor, including age, gender, or disease stage precludes them from participating. A mesothelioma specialist will help patients determine if compassionate use is an option.