Want More Diverse Enrollment? Slow Down And Listen To Patients

By Teri Crumb, MSN, RN, CCRC, TLC Research, LLC

The energy around increasing diversity in clinical trials continues to grow, with the first FDA draft guidance issued in 2019, refined in November 2020¹, and now bolstered further by the recently updated FDA draft guidance on Diversity Action Plans. The FDA mandates the design and execution of more diverse clinical trials that improve the inclusion of underrepresented populations. However, there are quite a few barriers, particularly the nitty-gritty details of trial design, that are limiting which patients can participate. What’s needed then are sponsor and site staff who are invested in digging deeper to better understand and support patients to drive more diverse patient enrollment.

Slowing Down At The Site Level

As a clinical research nurse with more than 20 years of experience, I have reviewed a wide variety of protocols and with each one, our team would talk about its inclusion and exclusion criteria. Though critical to the overall success of a trial in the FDA’s eyes, the I/E has the potential to limit enrollment of a diverse population. In one particular study, I recall exclusion criteria that prohibited the enrollment of participants if there was “poor adherence to medical treatments in the opinion of the investigator.” While screening for potential subjects, the PI and healthcare team would often label patients who didn’t show up for clinical care appointments as having “poor adherence.” As a research nurse, I understand that good research data comes from compliant subjects; it would have been easy to exclude these patients. But we needed to slow down and look at each one — in detail — to evaluate their barriers, assess their level of interest, and determine whether they could truly be a fit for the trial.

With one particular trial, upon consulting with the patients and their families, explaining that the study didn’t require an intensive schedule of visits, and stressing the importance of completing each visit, many shared with me that they couldn’t afford the taxi or ride share to attend the clinic visits.  One family lived in a very rural area. The gas money for an additional trip into the city would have to come out of their grocery budget. Another inner-city family didn’t have a reliable car and often had to use neighbors to get rides because a taxi was too expensive. Families with lower socioeconomic status (SES) typically have higher rates of transportation barriers to access healthcare². Pediatric trials are also known for difficulties with enrolling, as studies have shown that transportation is a major barrier for children³. However, this particular study had a reimbursement for travel, which provided the means for these families to participate. Our clinic also maintained flexible scheduling to accommodate families with children and their commitments involving school, summer vacations/camps, and holidays. Because of these accommodations, participants were eager to learn more about the trial and many ultimately said yes to the study — despite being nearly excluded from the outset. With more careful attention paid to the patients’ needs, we were able to assist with their travel accommodations as well as offer a flexible visit schedule, thus allowing us to enroll a diverse group of subjects in this trial.

Considering More Ways To Accommodate Patients

Although this study included travel reimbursement, not all studies do. However, there are other creative solutions to address this barrier for potential subjects, such as telehealth or home monitoring for the collection of data in trials. Sponsors need to envision opportunities where interval study visits are conducted with home health phlebotomy services (utilizing a central lab) and their assessments are done with e-visit or telehealth.  I’ve even seen a corporate contract with ride-share services set up where participants have a study access code to help with transportation barriers. When study visits require an early-morning start, such as for first-morning urine, fasting labs, or PK sampling, the sponsor could offer the participant a local overnight stay if their travel is greater than 50 miles. Sponsors might also consider the addition of a social worker or patient navigator⁵ at a site to help alleviate patient barriers to participation. A clinical research coordinator already has so many duties. Additional staff whocan assess barriers and identify community resources for things like rides or overnight accommodations (e.g. Ronald McDonald House or Hospitality Housing) would lessen the research coordinator's time and effort, allowing them to concentrate on screening, enrolling, regulatory compliance, retention, data entry, AE/SAE reporting, and ordering supplies, among other responsibilities.  

Diverse Enrollment Means Knowing Your Patients And Meeting Their Needs

In the fast-paced, pressured enrollment, and deadline-driven world of a clinical research coordinator, we often succumb to the easiest, straightest path to get our job done. In my experience, I have found that some patients need more time or more information to understand their commitment. Some need more support to get their next study visit scheduled. It often took more of my time to navigate the requirements of the study with some participants. My motivation to do this came early in my clinical research career after reading an article that notes that clinical trial participants have the added benefit of health monitoring through regular visits, disease or medication education, assessments by healthcare providers, and regularly scheduled labs/tests. Then in my work, I observed firsthand the participants in experiencing these additional benefits. It may have taken more of my time and energy to slow down and ensure their inclusion, but it was well worth it.

References:

1. Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research. Docket number FDA-2019-D-1264 Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry | FDA
2. Syed ST, Gerber BS, Sharp LK. Traveling towards disease: transportation barriers to health care access. J Community Health. 2013 Oct;38(5):976-93. doi: 10.1007/s10900-013-9681-1. PMID: 23543372; PMCID: PMC4265215.
3. Yang S, Zarr RL, Kass-Hout TA, Kourosh A, Kelly NR. Transportation barriers to accessing health care for urban children. Journal of Health Care for the Poor and Underserved. 2006;17(4):928–943.
4. Silver D, Blustein J, Weitzman BC. Transportation to clinic: Findings from a pilot clinic-based survey of low-income suburbanites. Journal of Immigrant and Minority Health/Center for Minority Public Health. 2012;14(2):350–355.
5. Nipp RD, Hong K, Paskett ED. Overcoming Barriers to Clinical Trial Enrollment. Am Soc Clin Oncol Educ Book 39, 105-114(2019).DOI:10.1200/EDBK_243729

About The Author:

Teri Crumb is a clinical research nurse. She has coordinated clinical research trials for over 25 years and has experience in multiple pediatric clinical areas. She has been a speaker at local, regional, and national research conferences. She obtained her BSN from Grand Valley State University, her MSN from Drexel University in Clinical Trials Research, and her certification through the Association of Clinical Research Professionals (ACRP). Her areas of interest are the training and education of clinical research staff. In 2022, she started her own LLC as a clinical research consultant.