Head & Neck
Clinical trials are studies that evaluate whether a new treatment, such as a drug, drug combination, surgical procedure, type of radiation therapy or a combination of therapies, is equally or more effective than the current standard of care. Some clinical trials may evaluate whether a new treatment that has fewer side effects may be as effective as the current standard of care.
Although it is often thought of as a last resort only, a clinical trial is a treatment option that can be considered from diagnosis through survivorship. In some cases, a clinical trial may even be your best first option.
A clinical trial is often introduced at diagnosis when you and your doctor are discussing your initial treatment plan, especially if your type of cancer has few or no approved therapies. A trial could also be incorporated into your treatment plan later if your cancer progresses, your current treatment is no longer effective or you are experiencing side effects that disrupt your quality of life. Sometimes, when cancer progresses, genomic testing may reveal a new mutation that may make you eligible for a clinical trial testing a therapy designed to treat that specific mutation.
Facing a life-changing decision is easier when you feel informed and safe. It is important to understand that most cancer treatments used today were once therapies or procedures that were developed, tested and evaluated through the clinical trials process to gain approval from the U.S. Food and Drug Administration (FDA). Understanding more about the process may help.
Learn more to move forward confidently
Generally, the studies happen in four phases. Each phase provides the building blocks of knowledge for the next phase. This approach allows researchers to ask and answer questions in a way that produces the most reliable information and provides the most protection to clinical trial participants. The process also ensures that only treatments that have been rigorously researched are approved for the public.
Based on the successes of other trials, the FDA recently has shortened its approval times for new therapies. Researchers have begun investigating and conducting seamless trials that begin in earlier phases. Today, the FDA considers approvals at any phase of research, including as early as Phase I trials, and approves therapies before many other countries’ organizations. These advances give patients the earliest possible access to lifesaving treatments.
Phase I evaluates a new drug (or other type of treatment) to see if it is safe for use in people. The goal is to determine how and when the drug should be given, and the dosage that will be most effective for killing diseased cells while causing the fewest side effects.
Phase II determines how well a treatment works and how safe it is in a greater number of patients.
Phase III compares the new treatment with the current standard of care to see if it is more effective or has fewer side effects.
Phase IV tests a drug that has already been FDA-approved for the market to gather more information about its effect in different populations and learn about long-term side effects.
How you can search for a clinical trial
While your medical team works behind the scenes to identify a trial that may benefit you, you can take an active role in your care by joining in the search. Here’s how to get started:
- Have your exact diagnosis, pathology report and details of previous treatments available. That will help you narrow the list of trials that are currently underway to those that may be a good fit for you.
- Search online. Many websites offer ways to search for a clinical trial. Some are customized to a certain cancer type; others are much broader. Generally, clinical trial search sites are hosted by the government, the National Cancer Institute, cancer advocacy groups, pharmaceutical companies and industry trade organizations, academic medical centers and major hospitals. No single list contains every open clinical trial, and new trials are continually being added, so check back often.
- Request assistance by phone. This is convenient for people who are not tech-savvy, do not have access to the tools necessary to search online or simply prefer to talk to a person.
As you search, look for trials that include your cancer type, age, location and the distance you are willing to travel. Once you find one or more trials you are interested in, talk with your doctor to determine whether you are eligible. Every participant in a specific trial must meet the same criteria to ensure the data gathered during the trial is valid.
Common criteria include cancer type, subtype, stage, biomarker status and treatment history. Keep in mind that you may not qualify for every trial that appeals to you. Some may be closed, or you may not meet eligibility criteria. For example, if a trial requires that you have already had a specific treatment and you have not, you will not be eligible.
Under certain extreme conditions, you and your doctor may apply to the U.S. Food and Drug Administration (FDA) to join a clinical trial that is closed or otherwise inaccessible. This is known as Expanded Access, also called Compassionate Use.
If you are interested in helping improve the future of cancer care but prefer not to participate in a therapeutic trial, consider a non-treatment trial that evaluates the following:
- Disease prevention and patient screening methods
- Diagnostic tools and procedures
- Genetic risk factors
- Ways to improve health and/or quality of life