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As the number of cancer diagnoses continues to rise, research is even more critical. In recent years, various programs and projects have been developed calling on researchers to work together to find new technologies, share data more easily, and develop much needed new diagnostic and treatment methods.
Clinical trials are an important step in testing a new drug, treatment approach, or diagnostic technique. Being able to test a new cancer drug, for example, on average takes at least six years to reach a Phase I clinical trial. The long years of development, however, can prove invaluable to current and future patients.
Clinical trials are crucial for advancing medical knowledge on what does and doesn’t work, and can potentially transform the standard of patient care.
Clinical Trial Basics
Every clinical trial begins with a master protocol developed by the principal investigator. The protocol lays out detailed plans for the trial including:
- The purpose of the study
- Eligibility criteria and the number of participants needed
- The schedule for participants’ tests, procedures, and/or dosages of drugs
- Length of the clinical trial
- What information will be gathered about the participants
For clinical trials studying cancer drugs and treatments, the trial typically goes through three phases before the drug can be approved by the U.S. Food and Drug Administration (FDA). Phase I clinical trials are generally the first study involving humans after the drug has gone through other laboratory testing. In each phase, more participants are studied to determine the safety and effectiveness of the drug, as well as any side effects. The American Cancer Society estimates on average it takes about 8 years for a drug to reach approval after going through all the clinical trial phases.
Not all clinical trials are designed to study treatments, and not all treatment-focused clinical trials are based around studying new drugs. Many clinical trials test the effectiveness of different diagnostic methods or ways to detect a disease and its extent. Some studies also work to determine ways to prevent these diseases altogether.
Thousands of cancer clinical trials are recruiting or active in the U.S. at any given time. Many are federally sponsored by the National Cancer Institute or other government agencies like the Department of Veterans Affairs. Pharmaceutical and biotechnology companies, medical centers, nonprofits, and other organizations also sponsor clinical trials.
Clinical trials are also overlooked by various review boards to ensure the safety of the patients participating. Every clinical trial has scientific oversight. This can be an institutional review board, an independent committee of medical professionals, or a federal agency like the FDA. Any National Institute of Health phase III clinical trial must have a Data and Safety Monitoring Board to review the trial’s data for any potential safety problems and differences in results among the groups.
Joining a Clinical Trial
Deciding to participate in a clinical trial is completely voluntary. It should be a carefully weighed decision with a patient’s doctor based on their individual diagnosis and best treatment options.
Clinical trials have their own criteria for what patients are eligible to join. This can include factors like age or medical history, and most often focuses on a particular type and stage of cancer. If eligible, patients will first need to sign an informed consent form. The informed consent covers essentially the same information as the master protocol, as well as the possible risks and benefits of joining the clinical trial.
The informed consent process is ongoing throughout the study. Should any new risks or side effects be discovered during the trial, the participants must be informed and sign new consent forms to remain in the trial. Again, clinical trials are voluntary and participants can choose to leave a study at any time before or during the trial.
In joining a clinical trial, participants must remember there are no guarantees. In many of these studies, participants are split into randomized comparison groups to test the new treatment or drug against the current standard treatment. This means some participants will not get to try the new treatment strategy to see if it can improve their prognosis. At the same time, even those receiving the experimental treatment won’t necessarily see benefits or better results.
Clinical trials, like any scientific study, face a lot of unknowns, which is where the risk lies. Patients face the possibility of unexpected side effects or the treatment proving to be ineffective. Clinical trials can also come with additional medical bills. Health insurance doesn’t always cover any additional testing, hospital visits, or other research related costs.
Ultimately though, the benefits of clinical trials go beyond an individual patient. In addition to the potential for receiving a promising new drug or treatment method, participants contribute to the important process of improving medical care. For rare cancers like mesothelioma, where patients often have limited treatment options available, clinical trials can be a ray of hope when facing a grim prognosis.
Importance of Clinical Trials for Mesothelioma Patients
As a notoriously difficult cancer to diagnose, mesothelioma typically comes with a very poor life expectancy. Mesothelioma often isn’t properly diagnosed until it has advanced to a later stage, where some standard treatment methods, like surgery, are no longer an option.
Mesothelioma is a very aggressive cancer. Only 55% of patients live beyond 6 months after diagnosis, and only 35% survive a year after diagnosis. Better treatment options are essential to help change the odds for these patients.
Emerging therapies, like immunotherapy, have shown promise for a variety of cancers, including mesothelioma. Keytruda® (pembrolizumab), an immunotherapy drug that targets proteins in cancer cells, has shown potential in some mesothelioma patients. Researchers have also seen encouraging early results in an ongoing clinical trial exploring the effectiveness of immunotherapy before surgery for mesothelioma patients.
Clinical trials can help researchers and doctors find the best treatment possible for patients and better diagnostic methods to find these diseases at an earlier stage. Every medical discovery stems from research, and clinical trials are a crucial part of the process.