Patient Navigators: The Missing Link to Help Patients Find Clinical Trials

Patient Navigators, who assist with improving health literacy and reducing barriers to accessing healthcare, can also fill an essential role in helping patients understand and find clinical trials, and other pre-approval treatment options, such as Expanded Access Programs.

Studies have shown that many people struggle to comprehend health information — and that this can have a negative impact on their health outcomes. It’s estimated that 80 million adults in the United States have limited or low health literacy. The European Health Literacy Survey found that nearly half of adults surveyed had inadequate health literacy skills, according to a report from the World Health Organization.

Health information is inherently complex, and clinical trials or Expanded Access Programs are no exception. Clinical trials, which are research studies to evaluate the safety and efficacy of drugs in development on patients’ health, involve complicated concepts and terminology. Expanded Access Programs are pathways for patients with serious, rare or life-threatening diseases to access drugs in development outside of clinical trials when there are no other treatment options available.

Most patients do not know that trials may be an option, let alone how to find clinical trials or be offered one. A recent study by the Fred Hutchinson Cancer Research Center published in the Journal of the National Cancer Institute found that almost a quarter of cancer patients do not participate in trials — not because of eligibility criteria that restrict which patients can enroll — but due to patient- or physician-related barriers.

However, researchers have found that a Patient Navigator can play an important role in not only explaining to patients that trials may be an option for them, but also in supporting recruitment and retention.

What is a Patient Navigator?

A Patient Navigator is often employed by healthcare organizations to provide health education to patients and help reduce barriers to accessing healthcare.

The Patient Navigator was first formally described in medical literature and implemented in 1990 by Dr. Harold Freeman, a surgeon in the Harlem neighborhood of New York City. He started the program because he noticed high rates of late-stage breast cancer and mortality in this predominantly Black community. Dr. Freeman employed navigators to educate women about breast health and address barriers to accessing care.

Patient Navigators have since become more widely used in cancer detection and treatment in the United States.

More recently, navigators have emerged in the context of clinical trials. They can play a role in helping patients understand how clinical research works, as well as help them find clinical trials and enroll in them. These professionals are sometimes referred to as clinical trial navigators.

By supporting patients in this way, they ultimately work to help bridge the gap between research and clinical care.

Are there clinical trials near me? A Patient Navigator has answers.

Clinical trials are an area where many patients may need assistance when it comes to boosting health literacy. Many patients are unfamiliar with the concept, while others who are aware of this option may wonder, “Are there clinical trials near me?”

For example, fewer than 5 percent of adult cancer patients in the United States participate in trials, according to the American Society of Clinical Oncology (ASCO). That contrasts with pediatric oncology, where more than 60% of children with cancer enroll in a clinical trial, and of these children, 75% live a long time after cancer, according to ASCO. Some oncologists contend that the increased accrual of adults into clinical trials could increase the survival rates in some adults with specific malignancies. Meanwhile, some cancer patients have wondered if navigators could help bring about this change.

“What if adult cancer patients were given the opportunity to consult with a trial navigator who would address rational and irrational concerns, provide a personalized list of available trials, and discuss their suitability?” wrote ovarian cancer patient Susan Gubar in the New York Times in 2019.

Patients are increasingly connected online through support and advocacy groups, and they often use the Internet to learn about their conditions and search for possible treatment options. They may also do a search for “clinical trials near me” to look for possible treatment options nearby.

How Patient Navigators at myTomorrows help patients find clinical trials

myTomorrows has created a patient-friendly solution to help patients (and caregivers) learn about all possible treatment options and find clinical trials. myTomorrows is a platform that links patients with an unmet medical need to treatments in development worldwide.

A Patient Navigator is assigned to each patient. They do more than just help patients find clinical trials. Each Patient Navigator is medically trained and supervised by a team of medical doctors. As skilled communicators with medical backgrounds, the navigators take the time to explain complicated medical terminology (e.g. molecular profiling, eligibility criteria, and clinical trial phases) in a way that is easier to understand. The team at myTomorrows serves patients around the world and speaks many languages, including English, French, Spanish, German, Italian, Dutch and Arabic. Meet one of our Patient Navigators.

The Patient Navigator guides patients through each step of searching for treatment options. Based on the patient’s medical record, myTomorrows uses technology to search clinical trial databases in over 200 countries and collects information about all available treatment options, providing answers to a patient’s search for “clinical trials near me.” myTomorrows shares this with patients and their physicians in a personalized document called a Treatment Search Report, which lists and explains all of this information.

myTomorrrows also created a patient-friendly document called a Patient Information Brochure, which provides an overview of the drug development process and explains how clinical trials and Expanded Access Programs work. This document was designed to empower patients to understand all possible treatment options.

Patient Navigators at myTomorrows help generate awareness in a disease area and clinical research in general, without promoting any specific trials. They answer the question, “Are there clinical trials near me?” and often field questions about how trials work and help patients understand the potential risks and benefits of participating in a trial.

Beyond helping find clinical trials, a patient navigator can facilitate enrollment

Although overall participation in trials remains low, many studies have shown that a Patient Navigator can play an important role in enrollment.

Some studies have shown enrollment rates of patients in clinical trials after receiving patient navigation to be as high as 95%. Many studies also refer to these navigators as clinical trial navigators.

“The wide array of patient barriers to clinical trial participation and navigator assistance documented in this study supports the clinical trial navigator role in facilitating quality care,” stated an article published in 2020 in Advances in Cancer Research.

An ongoing study at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University is reported to be the first time where the influence of Patient Navigators on clinical trial participation is being studied in a randomized, controlled trial study design

Patient Navigators and minority participation in clinical research

Studies have also evaluated the impact of navigators specifically on enrolling minorities.

Less than 10% of patients enrolled in clinical trials are minorities, according to the National Institutes of Health. There have been efforts in the United States to improve this — from healthcare organizations, patient groups and the pharmaceutical industry alike. Clinical trial participants should reflect the diversity of the population that is going to take the drug because race and ethnicity, just like age, gender, and weight, can affect how a patient’s body responds to a drug.

A study published in the Journal of Oncology Practice assessed Patient Navigators as a factor in the recruitment and retention of Black patients in clinical trials. It found that 75% of patients who were given a Patient Navigator completed their clinical trial compared to 38% of those who did not receive a Patient Navigator, and that the enrollment of Black patients into therapeutic clinical trials increased from 9% to 16% over seven years.

“The model holds promise as a strategy to reduce disparities in cancer clinical trial participation,” the study concluded.

Patient Navigators hold the future to how patients find clinical trials

Patients are more interconnected and empowered than ever before. Awareness of clinical research is gradually growing as more patients ask, “Are there clinical trials near me?”

However, lack of information is consistently a barrier to participation. There is a significant need for more awareness and education about how to find clinical trials and how to enroll in them — and Patient Navigators can play important role in this. Multiple studies published in medical journals have shown that navigators can play an important role in supporting enrollment, and even retention, in trials. Additionally, the successful use of Patient Navigators at myTomorrows — to help patients find clinical trials and access them — anecdotally supports these findings.

Our Patient Navigators serve patients and provide an innovative solution for pharmaceutical companies by supporting recruitment for trials, which are essential to drug discovery. As the pace of drug development remains critically important to both patients and pharmaceutical companies — and the number of trials continues to grow — the use of Patient Navigators is a strategic opportunity to make trial recruitment more efficient and effective.

At myTomorrows, Patient Navigators are at the heart of how we serve patients, and they play a defining role in our organization. Our Patient Navigators have helped more than 5,000 patients around the world driven by our simple belief that every patient should have access to all possible treatment options, including clinical trials and Expanded Access Programs. Our unique model is an example of how Patient Navigators can be the missing link in improving clinical trial participation as we work together to make drug development serve everyone better.