Cultural Competency in Clinical Research: Why It Matters and How Sites Build It

Cultural competency in healthcare and clinical trials has grown to an expectation during trail planning and recruitment. This growing expectation reflects the focus of diversity in trials to ensure the data better reflects the population that will use the investigative product (IP). This means that a clinical trail results ae only as good as the population that enrolls in them. 

This makes cultural competency in healthcare and clinical research more than an abstract idea, but a necessity for viable trail data. This impacts how informed consent is delivered and discusses and the trust the participant has in the site to support participant retention.  

What Cultural Competency Actually Means in a Trial Setting

Cultural competency in healthcare and clinical research is the ability of site staff, providers, and sponsors to view their patients and trial participants as unique individuals and not just a number. This involves intentionally considering the cultural, linguistic, religious, educational, and socioeconomic background of patients and study participants. This starts from the initiation of the trial planning though study design and procedures that do not alienate or exclude patients or trial participants. 

It is important to recognize that this is more than have in a translation service. A focus on cultural competency is much broader than that. 

Cultural competency involves the staff understanding and being able to effectively communicate how health decisions are made either as a in individual, as a family, or as a community. Understanding and addressing health literacy as separate from language fluency is important. It addresses pre-held ideas about illness, medication, and medical authorities which can also include mitigating previously established mistrust in healthcare and research systems.

This conversation should also explore practical barriers to receiving healthcare or participating in clinical trials such as transportation limitations, work schedules, and caregiving responsibilities that layer on to the complex cultural context. A fluent interpreter can help translate the ideas, but they may still fail at addressing the cultural context that goes into the patient or participants healthcare decisions. 

Why It Matters More Than It Used To

The FDA has been signaling that sponsors should be proactive in planning for diverse trial enrollment. This includes established diversity action plans for late stage trials to increase diversity. This means a site's ability to reach, enroll, and  retain a diverse population is becoming increasingly important, not just the total number of patients that are reachable. 

Increased diversity is important to ensure a true understanding of the IP effectiveness and potential side effects, adverse effects, or severe adverse effects in a generalized population. Overrepresentations of certain demographic groups, or under representation of certain demographic groups can provide a skewed assessment of the IP action. This is due to IPs behaving differently across demographic groups. Not only does underrepresentation raise ethical issues, it can leave safety and efficacy gaps in the effectiveness of the treatment as it reaches broader populations. 

There is a real distrust in healthcare and clinical trials for certain cultures as a result of historical events where certain populations were taken advantage of in healthcare and clinical research. Cultural competency ensures that each patient is treated fairly and is given the opportunity to trust the healthcare and research site staff. This emphasis on trust building is something that can be seen in recruitment and retention numbers. 

A focus, or lack of focus, on clinical competency can have true impacts on patient and trial participant recruitment and retention. A patient or participant who feels fully understood and is given time to feel comfortable will better trust the process and b less likely to drop out of the study early resulting in a protocol deviation. 

Building Cultural Competency in Day-to-Day Practice and in Clinical Research

Cultural competency shows up in the day-to-day healthcare and clinical trial practice and operations. 

During informed consent processes it is crucial to recognize the writing and reading level of the patients and participants can vary widely. It is important to recognize that translation does not result in comprehension. A conversation that is unrushed that allows for assessment of what was understood is important. Using teach-back methods, allowing time for questions, and being willing to provide the patient and potential participant appropriate time for questions is important. 

Language access can be a barrier for comprehension and needs to be considered as an aspect of cultural competency. A bilingual staff member informally translating is not sufficient, a qualified interpreter is required to protect the participant and the consent process integrity. Appropriate translation tools can be used to support basic understanding, but should not be used to replace qualified interpreters. 

Recruitment strategies should also be evaluated for their population and demographic reach. recruiting exclusively though specific channels can produce homogenous demographic pools. Partnerships and agreements to support recruitment of diverse populations help ensure a more generalized patient and participant sample. 

An often overlooked area for cultural competency is study logistics which may not align with potential patient or participant availability. Transportation limitations and schedule conflicts can be barriers to participation and retention and can negatively impact retention.

Understanding these aspects and building them into to trial plans can help increase the trials effectiveness. 

Building Cultural Competency Into Site Operations

Cultural competency for healthcare provider, staff, and clinical research site staff works best when it is incorporated into every day practice. Participant populations are dynamic, sponsor expectations are often shifting, and what is effective at one site does not necessarily transfer to another. 

For providers, staff, and research sites it is important to recognize that if you actually try and understand who you are trying to reach, build workflows around that evidence-based understanding, and investigate the gaps and reasons for recruitment drop offs you increase your positive results. his is more than good site operations, it is good ethics.