Head & Neck

Clinical Trials

Clinical trials may present many potential benefits, such as the opportunity for patients to access cutting-edge treatments that are not yet widely available. In fact, many of the advances in cancer treatment that are helping to save lives today grew out of research conducted through clinical trials. Depending on your diagnosis and other factors, a clinical trial may be an option, so it’s important to understand what it is and what it may mean for you.

Clinical trials are research studies that do the following:

  • Evaluate the safety and effectiveness of a medical strategy, treatment or device.
  • Develop “standards of care” by helping identify which treatments work best for certain illnesses or groups of people.
  • Offer opportunities for people with cancer to help others by being involved in clinical research.

Types of Clinical Trials

There are three types of clinical trials.

  1. Treatment Trials evaluate whether a new type of treatment (drug, surgery, radiation therapy) or a combination of treatments is better than the treatment options that are currently available.
  2. Quality-of-Life Trials study ways to improve the quality of life for people being treated for cancer and cancer survivors who experience cancer-related and treatment-related symptoms. This type of trial may evaluate the effects of such things as nutrition, group therapy or counseling.
  3. Prevention, Screening and Diagnostic Trials assess ways to reduce the chance of getting cancer in general. In these trials, which may be treatment or nontreatment trials, many participants do not have cancer, but some have had cancer and are at risk of the cancer recurring (returning) or a second cancer type developing. Sometimes these trials simply ask participants to complete questionnaires and provide medical information.

What to Expect

When you volunteer to participate in a clinical trial, you will receive specific instructions and an Informed Consent form. You are encouraged to ask questions about anything you don’t understand before signing and returning the form. This is the ideal time to talk with your medical team about the many falsehoods that persist about clinical trials. For example, one of the most common fears is that some participants will receive only a sugar pill (placebo) and will not be treated for their cancer. This is not true. Participants in a cancer clinical trial are guaranteed to receive treatment – either the experimental treatment or the current standard of care – during the trial.

Trials are carefully thought out, planned and performed in an extremely consistent manner so that all patients are treated exactly the same, from medication dosage and schedule to the frequency of follow-up appointments. Institutional review boards or ethics committees carefully set up safeguards to make sure that all participants in the clinical trial remain safe throughout the process. Whether you’re at a small hospital or a large facility, your medical team is responsible for diligently following safety protocols and measures for your treatment. You will be carefully monitored throughout the clinical trial. Even after the treatment ends, you will continue to be in close contact with the medical team.

Clinical trials present some potential risks, such as side effects. Almost every type of cancer treatment has side effects, and the treatments used in clinical trials are no different. If you consider volunteering for a clinical trial, talk with your medical team about what you can expect so you are not surprised by any effects.

It is important to understand that participation is always voluntary, even after the study begins. Even though you sign an agreement saying that you understand the potential risks involved, you can decide to leave the trial at any time. If your expectations aren’t met or if you experience too many side effects, you can withdraw and return to standard of care treatment.

Cost is a common consideration with clinical trials. Routine patient care costs typically include those related to doctor visits and hospital stays. Some testing procedures that are part of standard care may be covered by your insurance. Research costs, which are directly related to the clinical trial and include drugs and procedures, are typically covered by the trial sponsor. Before dismissing the idea of participating because of the cost, search for available resources and explore your insurance plan benefits. You may find that you can have access to an innovative treatment and be an integral part of cancer research without taking on a great deal of additional expense.

Use these resources to learn more about clinical trials and find ones that may be available to you.


Understanding Informed Consent

Before volunteering for a clinical trial, you will receive detailed information about the trial in an Informed Consent form. This customized Informed Consent information should explain – in easy-to-understand language – the components of the study:

  • The trial and its goals.
  • How the participant will be monitored.
  • The side effects to expect.
  • The best standard regimen of care for that 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.
  • How to withdraw from the trial at any time.

You should be given a reasonable amount of time to review this information. Write down questions to ask your doctor to ensure you understand everything before signing the form. You’re also encouraged to use this time to check with your insurance providers to determine what procedures are covered and what you 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, which would best be discovered before starting a trial.



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