While trials may be listed online in readily accessible databases, it can be hard to know what to search for and how to make sense of the medical jargon of the listings.
Clinical trials not only facilitate new drug development, but they can provide care to patients who desperately need more options, such as those with cancer. While trials may be listed online in readily accessible databases, such as those listed on clinicaltrials.gov, cancer.net and curesearch.org, it can be hard to know what to search for and how to make sense of the medical jargon of the listings. This creates a barrier between patients and clinical research. Not to mention that, unless their doctor is a researcher themselves, a doctor may not suggest clinical trials to their patients or even be fully aware of the clinical trials available.
So how do patients (and their doctors) learn about all the possible clinical trials and figure out which ones they could participate in? This is where a clinical trial navigator can help by finding and explaining possible trials, going through the complex patient requirements, and ultimately helping decide on a trial, if a trial is right for the patient.
A wonderful article in the New York Times written by Susan Gubar, an ovarian cancer patient, talks about the need for clinical trial navigators and offers a unique perspective on battling cancer and clinical trial participation.
Challenges with clinical trial participation
Fewer than 5% of adults with cancer participate in clinical trials, according to the American Cancer Society. This is in striking contrast with the fact that 60% of children (15 years and younger) with cancer participate in clinical trials, likely contributing to the rapid increase in the overall childhood cancer 5-year survival rate (more than 80% today compared with 58% in the mid-1970s).
Many childhood cancer patients participate in clinical trials, likely influenced by the fact that “85-90% of children are treated at academic centers,” Mitchell S. Cairo, Chief of Pediatric Hematology, Oncology and Stem Cell transplantation at New York Medical College, told Gubar. In contrast, only 10-15 percent of adult cancer patients are seen at academic centers. This greatly limits adult patients’ access to and knowledge of ongoing clinical trials they could participate in.
Increasing clinical trial enrollment of adult cancer patients would help drive new treatment options and could improve survival rates. But patients end up not participating in clinical trials for a variety of reasons.
Patients may not have easy access to the trial due to the location of the trial site, their access to transportation, or the time commitment of the trial visits. Patients may just be uncomfortable with receiving an experimental treatment. They may even worry about the unknowns of the experimental treatment, such as not being sure of its safety (one of the things tested in clinical trials), or not being treated fairly, as there has been some history of misconduct in research (although the rules and regulations today were enacted after reflecting upon those wrongdoings).
Cancer patients may also think they could receive a placebo treatment (an inactive drug or treatment, also called “sugar pills”) like many clinical trials have, but placebos are rarely used in cancer clinical trials (only when there is no standard of care). Placebos may be combined with the standard of care as a control compared with the standard of care plus an experimental treatment. This way, all patients still receive the standard of care and the trial can determine if adding the experimental treatment benefits the patients or not. However, patients are fully informed that they could receive a placebo treatment in addition to standard of care before they decide to participate in the trial or not.
Even patients who want to participate in clinical trials may not be able to enroll if they don’t meet the requirements, usually involving age restrictions, prior treatments they received, and other diseases or conditions they may have unrelated to their cancer. This begs the question of whether clinical trial inclusion and exclusion criteria for assessing potential patients are too strict. Trials have inclusion/exclusion criteria to ensure that the right patients are getting access to the experimental treatment not only to safeguard patient safety, but also to best control data parameters to make data analysis less messy. Clinical data is usually more complex than preclinical data, so researchers try to control some variables by imposing these criteria. However, controlling research data parameters must be balanced with testing drugs in a meaningful and realistic population. Recently, the National Cancer Institute (NCI) has been working to expand the exclusion criteria for NCI-funded trials, such as increasing the upper age restriction.
However, the main reason adults don’t participate in a clinical trial is still simply because they (or their doctor) are unaware of them. How can we help patients be more aware of their clinical trial options? That’s where clinical trial navigators step in.
What are Clinical Trial Navigators?
Clinical trial navigators are people who help cancer patients find clinical trials and determine which ones they are eligible for. They can be professionals, like nurses, or lay people, like cancer survivors. Clinical trial navigators are like a subtype of patient navigators (also called patient advocates). Patient navigators help patients understand the healthcare system and go through screening, diagnosis, treatment and follow-up appointments. Most cancer centers offer patient navigator services. Some cancer patient navigators may already talk with their patients about clinical trial options, but there are no consistent patient navigator guidelines between hospitals. Although the patient navigator field is largely not regulated, the Patient Advocate Certification Board created the Board Certified Patient Advocate (BCPA) certification in 2018 to lay down a set of operating parameters for patient navigators.
Clinical trial navigators (and patient navigators) were initially used to directly address the large gap in diversity seen in clinical trials. A study showed that clinical trial participants who received support from navigators were twice as likely to complete the trial than participants who didn’t work with navigators, and the percent of African American participants almost doubled (from 9 to 16%).
The Canadian Cancer Clinical Trial Network (3CTN) has a pilot clinical trial navigator program, where patients are either referred by their doctor or directly reach out to the program to be connected with a navigator. During the clinical trial navigator process (shown in a picture below from their website), a patient (or doctor) would sign up for the program, then a clinical trial navigator would review the patient’s medical history and search for clinical trials that the patient would be eligible for. The navigator would compile the potential trials into a report and give it to the patient’s doctor who would discuss it with the patient to determine which trial, if any, are best for the patient.
How can they help increase clinical trial enrollment?
Clinical trial navigators provide insight into what happens in clinical trials and guide a patient through the medical jargon of determining if they are eligible for a study. Navigators are resources to patients to guide them through the many decisions involved with cancer care, especially when clinical trials are involved.
Acting as a resource helps patients overcome barriers to healthcare, such as low literacy, poverty, or lack of health insurance. Especially in complex diseases like cancer, all patients (barriers aside) would benefit from some clear information and someone to guide them through the process.
Not only are navigators knowledgeable and able to filter through information (which a database could in theory do), they are a real person, someone the patient can talk with about how they are feeling and why they feel that way. This is especially true if the navigator is also a cancer patient of survivor; they’ve been where the patient is and can completely empathize with them.
By taking the burden off doctors to know all about available clinical trials (on top of everything else they have to know), it allows the doctors to focus on their decisions and gives the patient a better picture of their clinical trial options by having a dedicated person to just that portion of their care.
Clinical trial navigators would be especially important to have in non-academic hospitals to increase clinical trial awareness and enrollment. Non-academic hospitals tend to not focus on trials and, because most adult cancer patients go to non-academic hospitals, focusing on increasing information about and access to clinical trials at those hospitals would be impactful.
To find a patient navigator near you, contact the American Cancer Society at 1-800-227-2345, search on the National Association of Healthcare Advocacy (NAHAC) database, or search the Alliance of Professional Health Advocates AdvoConnection directory. More information about the Canadian Cancer Clinical Trials Network’s Clinical Trials Navigator program can be found on their website.
