Brain Tumors

Clinical Trials

To advance medical knowledge, research is needed, and much of that research is done through clinical trials. Clinical trials are essential for evaluating new treatments for people with brain tumors.

Each clinical trial is led by a principal investigator, who is usually a medical doctor. These studies also have a research team that can include doctors, nurses, social workers and other health care professionals. You will have regular visits with the clinical trial team, as well as visits with your regular doctor. Even after the treatment ends, you will continue to be in close contact with the medical team managing your trial.

Clinical trials are sponsored by government agencies, individual doctors and health care groups, or the pharmaceutical or biotechnology companies that developed the treatments. Because brain tumors are relatively rare, clinical cooperative groups also offer clinical trials. Clinical trials can be carried out at hospitals, universities, doctors’ offices and community clinics and in both large cities and rural towns.

Clinical trial participants must meet certain eligibility criteria, such as type and stage of disease, conditions specific to what the trial will study, age and overall health. Sometimes the results from diagnostic tests can be used to determine if you are a candidate for a certain trial. Ask your medical team about using existing tissue samples, blood test results and scan reports to avoid having additional procedures.

Exploring Clinical Trials

In addition to asking your doctor about available clinical trials, you are encouraged to do your own search for trials (see Find Clinical Trials). The advancements made through clinical trials save lives and help health care providers develop the best standards of care, yet people often hesitate to participate because they are not familiar with clinical trials (see Myth vs Fact below).

You might consider participating in a clinical trial for any of the following reasons:

  • Your current treatment may not be working as well as expected, and a clinical trial may be a worthwhile alternative.
  • A clinical trial may significantly improve your quality of life. Discuss your situation with your medical team so they are aware of your expectations regarding side effects.
  • You may have a rare type of brain tumor.
  • By simply participating, you play an integral role in helping refine and improve the way millions of people with all types and stages of cancer are treated. You will not only help identify treatments that work, you’ll help eliminate those that don’t.

Learn more by talking with other people who have participated in a clinical trial. Everyone has a different treatment experience, so you cannot expect to have an identical response to treatment or the same side effects. You can, however, find out what it’s like to receive care within a clinical trial. Regardless of the information you gather, participating in a clinical trial is your decision.

Safety Considerations

The conduct of clinical trials has been regulated by the U.S. Food and Drug Administration (FDA) since the 1970s. Its primary focus is to protect human participants while in clinical trials. To ensure compliance, all studies are conducted under the direct supervision of physicians and expert research professionals, and every participating clinic, hospital, university or cancer center, regardless of size or location, is subject to the same protocol. The protocol is a set of rules that outlines the eligibility criteria, specifies the tests that will be used and procedures that will be performed, describes the medications and their doses and establishes the length of each study.

You will be carefully monitored throughout the clinical trial. Clinical trials are all highly strategic and performed in an extremely consistent manner so that all participants are treated exactly the same.

 

Understanding Informed Consent

Potential participants receive detailed information about the clinical trial in an Informed Consent form. The Informed Consent information should be explained in easy-to-understand language and will include a description of the study’s purpose, the length of time of the study, predictable risks, possible benefits, expectations, protocols, alternative beneficial procedures or treatments, the research subject’s rights, where more information can be found and additional questions about the research. The document will include some of the following information.

  • The trial and its goals.
  • How the participant will be monitored and side effects to expect.
  • How to withdraw from the trial at any time.
  • The best standard regimen of care for the participants’ stage of disease, regardless of the doctor or institution.
  • The safeguards in place. All clinical trial participants are protected by rules that apply nationwide to all facilities.

The Informed Consent process should give the potential participants a reasonable amount of time to review the trial’s information and ask questions before volunteering. They should use this time to check with insurance providers to determine what procedures are covered and what they are expected or required to pay out of pocket. Although many trials cover the costs of certain treatments, other expenses may be the responsibility of the participants.

 

 

Myth vs Fact

MYTH: Clinical trials are only for people who have no other options for treatment (a “last resort”).
FACT: Clinical trials of cancer treatment may be available for individuals with cancer of all types and stages.
 
MYTH: Clinical trials involve treatments with unknown safety and efficacy.
FACT: Phase III clinical trials involve treatments that have been shown to be safe and effective in earlier phase trials. Phase III trials also include treatment with the standard of care, which has well-established evidence of safety and efficacy. Phase I and II trials are based on the results of preclinical trials showing the potential for efficacy and are carefully designed to ensure the safety of participants.
 
MYTH: The cost of care in a clinical trial is not covered by health insurance.
FACT: Patient-care costs (such as going to the doctor, hospital stays or certain testing procedures) may be covered by insurance. It’s common, but not guaranteed, for the trial sponsor to cover research costs directly related to the study, and insurance does not typically cover research costs. Any questions about coverage should be provided before entering into a clinical trial.

 

Additional Resources

 

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