How Cultural Competency Can Increase Clinical Trial Diversity

By Mel Hardman, DrPH, founder and principal strategist, Faces of Research

Technology, including telehealth visits, mobile applications, and wearables, helps researchers reach more people. However, it alone doesn’t alleviate the lack of diversity in clinical trials.¹ Once diverse patients are reached, how do we get them to feel safe, have trust, and be interested in participating in something they likely know very little about? With cultural competency.

Culture is an integrated part of a person’s behavior, and understanding someone else’s culture as it influences their behavior is cultural competency. Cultural competency is having a general knowledge of and respect for various ethnicities’ beliefs, customs, and values and using that understanding to relay information and provide education that is easily understood. In the life sciences, it gives way to transparent discussions about clinical studies — what they are, their safety, and the need for increased patient participation.

Achieving cultural competency should be the precursor to all recruitment and retention strategies for diversity goals.² Yet, it appears cultural competency in clinical sites is limited, and less-than-diverse recruitment data persists. It stands to reason that improving the cultural competency levels of clinical trialists would improve the chance of diverse patient recruitment and retention.

How Can Cultural Competency Help Boost Clinical Trial Enrollment?

As the world approaches the “crossover period,” at which time Caucasians will comprise a little less than half the population, around 49.7%³, it becomes increasingly important that clinical trialists foster appropriate attitudes about obtaining cultural competence and begin to develop knowledge of different cultures and the skills to engage with them. The goal, after all, is to achieve this understanding for the benefit of patient-centric healthcare, safer clinical trials, and more equitable and effective medicines. Differences in culture and understanding of culture between healthcare providers/site staff and patients affects the fluidity and comprehension of communication⁴. Treatment decisions can be impacted and not serve diverse populations in a positive manner. For instance, in some cultures, silence is a sign of respect. But if a site staff member is not aware or competent in a particular culture, they may mistake the silence for indifference or lack of concern, thus missing an opportunity for care.

Clinical staff with more experiences that reach all cultures have a better chance of creating a more diverse environment, thus a greater chance of enrolling and retaining diverse patients and cross-cultural communication is improved. Evidence suggests diverse clinicians that can relate to the diverse patient populations served improves patient health access and patient’s willingness to trust⁵.

Successful engagement with minority participants can lead to improved enrollment and retention and, hopefully, a greater chance of developing effective drugs. On the other hand, failure to retain minorities could mean less effective drugs (in some populations) and even the risk of failed trials altogether, which costs sponsors money, CROs time, and sites… well, patients. Everyone loses, but especially patients in need.

As clinical trials are increasingly considered a care option as opposed to a standalone entity, improving diversity in clinical trials can improve the state of health inequities. While focus has long been on educating the patient population, there is now a shift toward educating the clinicians in ways to engage with and relate to diverse populations to improve the relationship between minority communities and the drug development industry. Cultural competence can be that bridge.

Cultural Competency Can Benefit Sponsors, CROs, Sites — And Patients

The industry has moved beyond talking about improving diversity and expecting the underserved populations to come running toward clinical trials with open arms. Instead, it’s taking the care, the education, and the trial knowledge to them. That begins with training programs for clinical site staff to learn best practices to carry this function forward.

Given the FDA requirements for diverse patient enrollment, sponsors need strategies to meet these guidelines, CROs need tactics to implement the successful strategies outlined by sponsors, and sites need the tools to engage appropriately with patients of interest. The FDA recognizes that cultural competency barriers — such as language barriers, conflicting caregiver and family responsibilities, health literacy, and lack of awareness by the target population and the clinicians — hinder more diverse patient enrollment.⁶ What’s more, these populations also tend to feel mistrust and experience a lack of access and lack of engagement and understanding. Thus, by improving cultural competency on all levels, the sponsor, study team, and site staff have a greater probability of improving recruitment of diverse patients into clinical trials.

Cultural Competency Training In Action

In a recent study, researchers implemented a culturally appropriate, community-based approach to help sites improve cultural competency and improve engagement with potential trial participants in COVID-19 trials where participation of minority patients was critical but lacking.⁷ The team worked closely with clinicians to provide engagement training on culturally appropriate messaging, competency tools, barriers, equity concerns, and even access points.

To improve the competency of staff around culture of blacks and Hispanics, training manuals were developed that provided insight on culturally appropriate nuances and behaviors. To help bridge the gap with potential patients in the community, clinical trial knowledge pamphlets were created with culturally appropriate, with easily comprehendible language, trial accessibility information for low income and urban patients, updated FAQs to include questions researched to be most often asked by diverse and minority participants, and culturally diverse images. The sites even addressed the lack of patient trust by making sure the patients felt appreciated, supplying water, providing thank you “goodie” bags, and even letting patients tour the facility to reduce anxiety about being at a clinical trial site, where for most this would be the first visit of any kind.

Because the staff was culturally competent toward the needs of the minority community, they were better equipped to produce an environment more conducive to building trust and inclusivity, which led to greater impact and enrollment. They found cultural competency tools can provide “critical and timely insight” into their community and help alleviate barriers and improve recruitment and retention of diverse patients.

Research by Okoro, Odenima, and Reams⁸ back this up. They created an atmosphere of self-reflection and learning for pharmacy students. The intervention involved a cultural competency training determined to improve the pharmacy students’ attitudes, ideas, and knowledge around health disparities and cultural differences⁹. The researchers understood a clinician’s cultural competency level affects the way they respond and engage with patients. The outcomes and results of the training showed students experienced an increased awareness of health disparities and differences in cultures.¹⁰

Personal Perspective: Determining Bias & Facilitating Cultural Awareness Training

I, too, have facilitated cultural sensitivity and engagement training to sites and can attest to improved attitudes toward cultural competency and the need to improve engagement within diverse populations.

The training I developed began with a pre-survey adapted from the Clinical Cultural Competency Questionnaire to determine any bias clinical staff had and/or quantify their current attitudes toward diversity and cultural competency importance. Examples of questions included are:

 “Do you feel comfortable engaging with diverse populations?”

“How knowledgeable are you on health disparities among different ethnic groups?

 “Are you familiar with social cultural characteristics of different ethnic groups?

Even during focus groups and open discussion I candidly asked clinical site staff their position on the importance of cultural competency, their attitudes toward the need to spend time learning to engage, and their desire. Often, minority staff members understand the importance. Non-minorities, though, would be a bit more hesitant to admit its significance, ironically making light of the obvious gap.

My aim then was to provide a “train the trainer” type environment that was open, informal, and non-intimidating, so site staff didn’t feel overwhelmed or nervous to participate. The training provided information on minority populations most likely to be treated in their area according to census demographics near their sites. Sections in the training included what good cultural competency should look like and suggested practices for developing a good culturally competent site including staff make up, cultural experiences, and engagement tactics. Because community engagement is important in building trust in minority communities, information on building partnerships with communities was also provided.

The post-training surveys showed significant improvement in the staff’s desire to be culturally competent and its importance to diversity recruitment. I also received written responses about how grateful they were for the training. In some cases, clinical staff admitted they have biases that are not “purposeful” but the training helped them to recognize them and how to address them to improve their connections with diverse patient populations.

Whether we believe it or not, we all have biases. Some biases are known, others are unknown. Creating a space for all patients to feel safe and important begins with cultural humility, a cornerstone of cultural competency. Humility allows us to be honest about our true feelings, biases, and preconceived beliefs regarding certain cultures and ethnicities and begin addressing them and stripping them away to become more culturally sensitive, and then culturally aware, and then culturally competent.

A goal of cultural competency is to be able to respond to a person’s unspoken cultures rather than viewing them based on what is visible. The goal is for people to become competent, and maybe even proficient, in recognizing cultural differences and removing any existing biases that would cause he or she to give or take away power based on those differences.

How To Start Your Cultural Competence Strategy

Cultural competency improvement begins with a shift in the mindset of clinical staff. Begin with seeking online or facilitator training to provide educational resources for a site. Even if the site has been through diversity training, which often explores the need for minority recruitment and its importance to the clinical development industry, cultural competency training should be the next step. Competency training creates the “how” to diversity training’s “why.”

When searching for training, keep in mind cultural sensitivity, cultural humility, and cultural bias training are all great options for cultural competency training. Of course, even the smallest step can help. Consider self-training, which begins with identifying biases and working on removing them while engaging with minority patients.

References:

1. Khan, Zara (2022). Opportunity to Improve Research: Clinical Trial Diversity. Revive
2. Research Institute. Clinical Trial Diversity: Opportunity to Improve Research (reviveresearch.org)
3. Frey, William (2018). Diversity Explosion. How New Racial Demographics are Remaking America.
4. Tulane University (2021). How to Improve Cultural Competency in HealthCare. How to Improve Cultural Competence in Health Care (tulane.edu)
5. Caraveo, Clara and Allen, Eva (2022). Diversifying the US Healthcare Workforce isn’t enough on its own. Urban Wire. Diversifying the US Health Care Workforce Isn’t Enough on Its Own | Urban Institute
6. Heath, Sara (2020). Patient Engagement Hit. Outreach, Cultural Competency Key to Clinical Trial Diversity 18(1), 232.
7. Spinner, J. & Haynes, E. (2021). Enhancing FDA’s Reach to Minorities and Under-Represented Groups through Training: Developing Culturally Competent Health Education Materials. Sage Journals (101) 12.
8. Okoro, O. N., Odedina, F. T., Reams, R. R., & Smith, W. T. (2012). Clinical cultural competency and knowledge of health disparities among pharmacy students. American journal of pharmaceutical education, 76(3).
9. Castellon-Lopez, Y., Landovitz, R., Ntekume, E., Porter, C., Bross, R., Hilder, R., Lucas-Wright, A., Daar, E. S., Chavez, P., Blades, C., Carson, S., Morris, D., Vassar, S., Casillas, A., & Brown, A. (2022). A community-partnered approach for diversity in COVID-19 vaccine clinical trials. Journal of clinical and translational science, 7(1), e23.

Robert, Nigel. (2018, June 5). Blacks underrepresented in 'Life and death' clinical research, study finds. NewsOne.

About The Author:

Dr. Hardman, affectionately known as the “engagement” doc, is a clinical research professional with 28 combined years of progressive healthcare management and clinical research experience. She has spent the last 10 years working in site, patient, and community engagement in the clinical trial space. She has found her niche in engagement activities, building relationships and strategizing with sites to determine and mitigate barriers to recruitment. Her passion is creating a voice for the underserved and minority populations as it relates to clinical research and health equity.

Dr. Hardman is the founder and principal strategist of Faces of Research, a small clinical research strategy consulting firm. Dr. Hardman completed her Doctor of Public Health using her efforts and work in the clinical trial industry, creating a cultural competency training deck to provide training to clinical trial staff focused on improving minority recruitment and retention. She also holds a Master of Science in Clinical Research Administration, Master of Public Health, and Bachelor of Science in Health Science and Biology. She can be reached at mel@facesofresearch.net.