Head & Neck

Clinical Trials

Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for people. Clinical trials also may show which strategies work best for certain illnesses or groups of people. To participate in a clinical trial, you must meet certain eligibility criteria, such as cancer type, overall health, treatment history, etc.

You may consider participating in a clinical trial for the following reasons:

  1. Your current treatment may not be working as well as expected, and a clinical trial may offer a worthwhile alternative.
  2. A clinical trial may significantly improve your quality of life. Discuss your personal situation with your health care team, so they are aware of your expectations regarding side effects.
  3. You may have a rare type of head and neck cancer that hasn’t been studied as much as other types.
  4. By simply participating, you’ll play an integral role in helping refine and improve the way millions of people with all types and stages of head and neck cancer are treated. Your participation will help researchers identify those treatments that are effective.

Although all cancer treatments in use today came from clinical trials, patient participation could be improved.

Fear of the unknown may prevent people from participating. Consult with your doctor and the health care team that will be conducting the clinical trial. Talk with people who have participated in clinical trials, but remember that not everyone responds to treatments in the same way. You cannot expect an identical experience in terms of response to treatment, side effects, etc.

The cost of clinical trials is another reason people hesitate to volunteer. Under the new health care laws, 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 discussed before entering into a clinical trial.

People may hesitate to volunteer because of the many misconceptions about clinical trials (see Myth vs Fact below). Be your own best advocate, and learn more about clinical trials so you can make an educated decision. People often find they have more positive treatment experiences when they are educated about and actively involved in decisions about their care.

 

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: Some participants in a clinical trial will get a placebo instead of treatment.
Fact: Participants in cancer clinical trials will usually receive the standard of care as a foundation and then the experimental treatment or a placebo will be added to it. In some clinical trials, patients receive a new therapy and some patients receive the current standard therapy. Although rarely the case today, if a placebo is used, study sponsors are required to disclose this information to patients ahead of time so that they can make an informed decision about participating.

Myth: A clinical trial must be recommended by a doctor for a person to participate.
Fact: If your doctor does not talk to you about clinical trials, raise the topic yourself. You can also search for clinical trials online using the list at the back of this guide.

Myth: Clinical trials are not safe.
Fact: Clinical trials have many built-in safeguards to ensure that participants’ rights and safety are protected. These safeguards include an institutional review board, a data and safety monitoring board, and an ongoing informed consent process.

Myth: Clinical trials only take place at large hospitals or cancer centers.
Fact: Many clinical trials take place at local hospitals, cancer centers and doctors’ offices. Clinical trials occur in all parts of the country, in both rural and urban areas.

Myth: Signing a consent form to participate “locks” you into staying in a trial.
Fact: Even after you have signed a consent form, you are free to change your mind and not participate. You can leave a trial at any time for any reason.

 

 

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