Boosting Clinical Trial Enrollment by Reducing Participation Barriers

Patient recruitment for clinical trials is an essential, yet elusive, part of clinical research.

More than 80 percent of clinical trials globally fail to meet enrollment goals, which may result in delays that are not only costly but also may have an impact on the lives of patients with unmet medical need who are waiting for new treatments.

There has been increasing research into how to improve patient recruitment, much of it focused on reducing barriers to participation.

To better comprehend these barriers and how to reduce them, it helps to walk in the shoes of each stakeholder — patients, physicians, and clinical trial site staff. By beginning to understand their pain points, we can begin to break down these barriers in a way that is meaningful for each stakeholder and ultimately improve patient recruitment for clinical trials.

This blog provides just a small glimpse into strategies for maximizing clinical trial enrollment.

Finding clinical trials as a patient

As patients should be the first priority, let’s start by looking at barriers faced by patients and their families.

Most patients do not even know that a clinical trial could be an option, let alone how to find a clinical trial. For example, a study by the Fred Hutchinson Cancer Research Center published in the Journal of the National Cancer Institute in 2019, showed that almost a quarter of patients with cancer do not participate in trials — not due to eligibility criteria that determine which patients can enroll — but because of patient- or physician-related barriers.

For instance, patients may lack education about clinical trials and how they work, or they may not have adequate access to a cancer center and/or the necessary transportation. Taking time off work and finding childcare in order to participate in a clinical trial can also be hurdles for patients and their families.

Studies have shown that Patient Navigators can play an important role in explaining clinical trials to patients, as well as supporting recruitment and retention.

The Patient Navigator concept was first introduced in 1990 in Harlem by Dr. Harold Freeman after he noticed high rates of late-stage breast cancer and mortality in this predominantly Black community and decided to employ navigators to educate women and address barriers to care. Since Dr. Freeman’s pioneering work, Patient Navigators have become more widely used in cancer detection and treatment in the United States.

In order to reduce some of the many barriers that patients face when trying to find and access clinical trials, myTomorrows began using Patient Navigators more than a decade ago.

A Patient Navigator is assigned to each patient who reaches out to myTomorrows, so the patient has one point of contact at myTomorrows during their entire journey.

How Patient Navigators can help

Patient Navigators do more than just help patients find clinical trials. As skilled communicators with medical backgrounds, they take the time to explain complicated medical concepts in a way that is easier for patients to understand.

Our Patient Navigators speak 10 common languages, and they also use additional translators to help families in their native language as needed. For example, in just the last month, they assisted patients in the following languages: Spanish, French, Italian, Russian, Ukrainian, Hindi, Arabic, Dutch, Farsi and Mandarin.

myTomorrows collaborates with the Akari Foundation to help Spanish-speaking families learn about clinical trials for Duchenne muscular dystrophy. Our Spanish-speaking Patient Navigators are available to assist Duchenne families with finding clinical trials and understanding how they work.

Luisa Leal, founder of the Akari Foundation, explains why this is so important for families.

“When families are faced with sensitive medical decisions and receiving rare disease diagnoses, it is difficult to deal with the overwhelming and technical concepts and knowledge involved in clinical trials,” Leal said.

A language barrier makes it incrementally more challenging.

“It is even more difficult to process, understand, and make the right decision for our children when information is not in our native language,” Leal said. “It is essential and vital that this information is not only more digestible for families but also in their language, to overcome language and knowledge barriers.”

Facilitating access to clinical trials for physicians

Physicians also face barriers when it comes to finding and accessing clinical trials for their patients. In addition to extreme time constraints, physicians may face challenges such as being unfamiliar with eligibility criteria and with the clinical trial enrollment process.

myTomorrows was founded and is led by physicians. Our medical team understands the challenges that physicians face in their efforts to find and access clinical trials for their patients, and we support them each step of the way.

Physicians can use our proprietarily developed search tool to perform a rapid and accurate global search of registries to identify clinical trials at any time. Alternatively, we can conduct a search for them and present them with a list of possible options for their patient based on the patient’s medical information.

If a physician and patient decide to pursue enrollment in a clinical trial, we will try to help them.

Our platform compliantly connects physicians to principal investigators and clinical trial sites through tailored workflows and is supported by our medical team. We strive to bridge the gaps between patients, physicians, and clinical trial sites.

Barriers at clinical trial sites

Clinical trial sites are at the heart of clinical research. However, they often have a lack of resources and a limited ability to provide information and support to patients and their caregivers. Heavy workloads and emotional stress also may take a toll on clinical trial site staff.

Clinical research associates in the United States have a turnover rate of 30 percent, compared to a 19 percent turnover rate in the United States overall. Clinical trial sites also face notable staffing shortages.

Principal investigators face the challenges of coordinating and communicating with treating physicians and patients.

myTomorrows understands that clinical trial sites must become an integral part of the clinical trial recruitment funnel. Our platform approach helps streamline coordination and communication channels with clinical trial sites — reducing the administrative burden on clinical trial site staff.

Further, our unique pre-screening and triaging process saves time for clinical trial site staff. Our solution generates a flow of highly qualified patients who are willing to enroll to sites, which reduces on-site screening failures — ensuring minimal drop-off at clinical trial sites and boosting on-site screening performance. Our process, which involves the sponsors and CROs, allows for better follow-up and overall coordination.

Overall, our platform approach enables tailored digital workflows via dedicated portals for key stakeholders involved in the recruitment process — patients, physicians and principal investigators/clinical trial site staff. Our platform compliantly connects these stakeholders in order to expedite clinical trial enrollment.

myTomorrows is dedicated to enabling earlier access to all possible treatment options. We have helped more than 10,000 patients, 1,000 physicians and 50 well-known BioPharma companies.

We partner with innovative BioPharma companies to provide​ pre-screening and triaging services for clinical trial recruitment and Expanded Access Programs with Real-World Data collection.​

Learn more about how myTomorrows can help boost clinical trial enrollment by reducing barriers to participation.