Thought Leaders Explore New Ways to Promote Clinical Trial Diversity

Photograph of Liz Beatty

Liz Beatty, Co-Founder & Chief Strategy Officer, Inato

There’s more to the quest of fostering diversity, equity, and inclusion in the delivery of clinical research opportunities than just reaching race/ethnicity-, gender-, and age-related goals for patient recruitment. For example, geographic diversity can also be of benefit to widening the applicability of trial results and ensuring safety of new therapies in greater ranges of real-world populations, but location may be as much or more of a barrier to a potential participant’s ability to join a trial as other factors. This may especially be the case when the would-be participant lives in a deeply rural area that is underserved in terms of study sites.

ACRP reached out to a quartet of clinical trial thought leaders on the subject of connecting researchers and participants to each other and available trials to gauge the latest trends in broadening the scope of studies in the face of geographic challenges. Sharing their insights with us were Andrea Bastek, PhD, director of innovation at Florence Healthcare; Liz Beatty, chief strategy officer for Inato; Colleen Hoke, cofounder and CEO of ObjectiveHealth; and Harsha Rajasimha, MS, PhD, CEO and founder of Jeeva Informatics Solutions Inc.

ACRP: From your experience, how can patient recruiters best reach potential participants in deeply rural areas, and why are such efforts important?

Photograph of Andrea BastekAndrea Bastek: Patients from very rural areas often incur a very high burden to travel to an urban research center. [I’ve had patients from such settings who] were eligible for potentially life-changing therapeutic trials, but without financial support would not have been able to participate. It is critical that sites negotiate meaningful stipends or accurate reimbursement and that sponsors recognize this need. There must be a way to fairly compensate patients without fearing accusations of coercion. Most importantly, recruiters can and should ASK patients what their burdens are, and what they really need in order to be able to participate. It may be embarrassing for patients to admit that they need this financial help, so finding an unassuming and non-judgmental way of having this conversation will be important.

[Seen through the lens of our COVID-19 experiences], it is easy to imagine how [many types of simple site] visits could be replaced by a telehealth call, an eConsent tool, and an electronic patient-reported outcome system. By using technology to reduce the number of visits, rural patients will be much more likely to consider participating in a trial. One point to highlight here is that it may also be important to provide technology and WiFi service for that technology in order for some rural or minority patients to participate. Having these options negotiated and available for recruiters is an important part of planning for success.

[However, while] technology can reduce the burden of traveling to participate in a study, it can create its own burden of intimidation. The prospect of using new technology can be overwhelming and frustrating for patients who do not have regular access to such technology. It may be embarrassing for patients to admit that they don’t know how to use technology, or that they do not have regular access to a specific device or WiFi. Offering access to all patients in a compassionate and non-judgmental way—and not making assumptions about any patient’s access, knowledge, or ability—will help create an open environment where patients feel comfortable asking for and accepting resources.

[We must also recognize that] many rural patients look to leaders in their community or their long-time local physicians for advice about illness, therapy options, and clinical trials. Building a relationship with these influential people can help with recruitment in those areas. Specifically for local physicians, having open discussions about the trial visits; what visits, tests, or procedures might be done locally; and what the partnership for care will look like is critical to receiving support from any referring physician.

Liz Beatty: Historically, sponsors have been hesitant to work with previously unknown sites. However, these are the exact sites needed to break into these underserved communities. In rural areas, one research center can be the singular point of care for every patient within a 200-mile radius. This gives them broad access to a wide variety of diseases and demographics, making them a valuable addition to any trial.

As ingrained members of the communities, these sites already have trusted relationships, proven experience enrolling, and knowledge of the unique support needed to engage with their patients. They commonly have existing programs to help with travel, food, stipends, and community outreach. By partnering with these sites and highlighting their past experience, we can increase sponsor confidence and bring clinical trials to thousands of previously underserved patients.

Photograph of Colleen HokeColleen Hoke: [Looking at it from the investigator’s perspective], decentralized clinical trials (DCTs) virtually eliminate geographical barriers for investigators participating in clinical research as onboarding practices—from required trainings to data collection—can be conducted and examined remotely. …[As for recruiting patients], while subjective to each patient and their unique circumstances, DCTs have provided more flexibility in clinical trial participation, which can be argued to have directly impacted patient retention. The fewer the site visits, the fewer the logistical obstacles that often get in the way of keeping a study, and participating patients, on track.

…[However], we understand that the tried and true method of partnering with local physician offices to engage individuals in research will continue to play a key role in patient recruitment, especially when recruiting a diverse patient population. Being at the point of care fosters trust with the patient such that, even though communication, coordination, or recruitment may be digital, they already have a relationship with our team because they work within the practice. So even though recruitment and enrollment may take place digitally, our approach is still warm and intimate, as opposed to being cold and distant, which can occur when patients don’t feel connected to their care teams. …In-person appointments may still be more convenient for some patients, so it is key for research sites to be as patient-centric as possible when putting together initial steps. 

Photograph of Harsha RajasimhaHarsha Rajasimha: Clinical researchers aiming to reach patients in deeply rural areas to increase trial diversity need to strike a balance between convenience, compliance, cost, and continuity during unexpected scenarios such as COVID-19, [and] should find a flexible eConsent solution that can support [several goals and functions]:

  • Enabling remote electronic informed consent, in-person electronic informed consent, and paper-based informed consent as a backup. Offering choices and options can enable better recruitment and patient experience.
  • Granting access by prospective patients to clinical study information from their own device in multimedia formats. Relying on the traditional approach of informed consent forms that are 30 to 70 pages is a recipe for enrollment delays.
  • Allowing enough time and convenient means for the potential participants to ask questions and seek clarifications by e-mail, SMS, audio, or video calls.
  • Verifying patients’ comprehension of the trial by designing a scored quiz or questionnaire, especially when informed consent is obtained remotely.

Edited by Gary Cramer