Patients who are interested in clinical trials often feel overwhelmed trying to understand when and if they are eligible to enroll in a clinical trial.
Understanding Clinical Trials
A clinical trial is a research study to test the safety and effectiveness of new medical treatments, devices, or therapies. Participants are assigned to one or more treatments (which may include a placebo or other control) to evaluate the effects of those treatments on cancer outcomes.
Clinical trials pave the way to discovering new medical advances and treatments for incurable diseases, such as glioblastoma.
Looking for more information? Watch Dr. Mark Johnson, Chair of Neurological Surgery, University of Massachusetts, explain why clinical trials are important for individuals with primary brain tumors and learn how our Navigators can assist you in your next clinical trial search.
Are you interested in the latest brain tumor treatments?
Our Navigators provide information to help patients understand when during the treatment journey a clinical trial may be appropriate for them. Navigators perform personalized clinical trial searches utilizing molecular information specific to each patient’s brain tumor, matching them with the most appropriate trials for their individual diagnosis.
Frequently Asked Clinical Trial Questions
There are several reasons individuals may choose to participate in a clinical trial:
- You may receive a new treatment that may be more effective or better tolerated than what is currently available through a prescription from your doctor.
- Researchers and specialists may provide more frequent medical care and monitoring as part of your treatment.
- Joining a clinical trial is a step toward finding a cure for all primary brain tumors. The clinical research you are involved in could help future generations battling the same diagnosis.
Yes. All clinical trials carry some risks:
- The experimental treatment may not work, or it may be less effective than the current standard treatment.
- The experimental treatment may require invasive procedures such as surgery or may cause serious side effects.
- If enrolled in a randomized trial, you may not be part of the experimental treatment group, but instead receive the standard treatment or a placebo
It’s important to note that clinical trials have stringent guidelines and are overseen by regulatory authorities to minimize risks and protect participants’ safety.
When exploring clinical trial options with your navigator, it is important to understand how each study is designed:
- Randomized – A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions. At the time of the trial, it is not known which treatment is best.
- Nonrandomized – A study in which participants may either choose which treatment group they want to be in or are assigned to groups by the trial researchers.
- Single-Group Assignment – All trial participants receive the same intervention or treatment.
- Blinded – A study in which participants do not know what is being given to you but the research team knows. This is to prevent the research team and the participant from influencing the results.
Clinical trials are divided into four phases. Each new treatment must pass all four phases before it can be approved by the U.S. Food and Drug Administration (FDA) and adopted as the new standard of care:
- Phase I – Tests if a new treatment is safe in humans. Phase I studies tend to enroll a small group of patients to assess safety and possible side effects. In a Phase I trial, doctors are also monitoring whether participants’ brain tumors are responding to the treatment.
- Phase II – Tests how one specific type of cancer responds to the new treatment. Study groups tend to be larger than in Phase I (roughly 50-200 patients) to evaluate the treatment’s effectiveness and collect more safety data.
- Phase III – Treatment is expanded to hundreds or thousands of patients across the country. In Phase III, researchers are looking to see whether the new treatment works as intended and to compare its effectiveness to other existing therapies.
- Phase IV – Following FDA approval of a new drug or treatment, researchers continue to monitor the safety, benefits, and risks of the treatment with the help of long-term research volunteers.
Informed consent is a voluntary and ongoing agreement that allows individuals to make an informed decision about their involvement in a research study. It ensures that potential participants understand the study’s purpose, procedures, risks, and benefits before they decide to participate.