Achieve the Results You Want from Your Diversity Action Plans
In June 2024, the US Food and Drug Administration (FDA) issued a long-anticipated draft guidance to address the recurring issue of a lack of diversity in clinical trials. Titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” this document fulfills the 2022 Food and Drug Omnibus Reform Act (FDORA) requirement to issue new or updated draft guidance.
The historic lack of diversity in biomedical research in general and particularly in clinical trials has become a pressing issue with far-reaching negative impacts on public health. Historically, clinical trial enrolment has been biased towards younger Caucasian males. This has been the case even when researching conditions where underrepresented populations are disproportionately affected. This is more than just an abstract issue and a question of right and wrong; it is essential for obtaining reliable efficacy and safety data from clinical trials of drugs and medical devices. Safety and efficacy can differ between various groups. Only by enrolling representative samples of the population who will receive those therapies can we ensure that our data is valid.
Conditions may not only be experienced differently by different groups of people, but factors such as environmental conditions, age, biological sex, life experiences, behaviors, comorbidities, and genetic and geographic background can impact the risk of experiencing specific health conditions, outcomes, and treatment response. However, enrolling a diverse group of participants is associated with numerous challenges for minority populations; these range from historic mistrust to lack of information and access to healthcare and logistical challenges such as transportation to cultural and linguistic barriers.
Strategies for improving diversity in CT enrolment
The draft guidance recommends several measures to increase the inclusion of minorities, including sustained community engagement. In ethnic minority communities, these efforts are hampered by cultural and linguistic challenges such as limited English proficiency (LEP). This term refers to individuals whose primary language is not English and who need help understanding and communicating in English. For example, this could include recent immigrants from countries with other national languages, and the issue could be compounded by disabilities or lower educational achievement. Cultural differences further complicate engaging with these minority populations.
The guideline further suggests cultural competency and proficiency training for investigators and research staff. However, this may not be practical when interacting with communities of different cultural and linguistic backgrounds, especially when multiple research sites are involved. However, it is important to engage with these participants and reduce bias and generalization during these interactions. In addition, the guideline recommends improving awareness and knowledge of clinical trials. How, then, can successful communication and engagement be achieved?
None of these efforts are likely to be successful without professional language assistance.
While it may be tempting to rely on community members with higher English proficiency to communicate, this approach needs to be revised from an ethical and compliance perspective. Working with experienced, professional translators and interpreters, ideally vetted by a quality language service provider, has several key advantages crucial to successful engagement and communication.
Maintaining Neutrality
In addition to their linguistic expertise, certified interpreters and translators must maintain neutrality and objectivity, whereas community members may be more emotionally involved. Working with professionals removes bias and is crucial within the context of sensitive medical content. Furthermore, they are bound to maintain confidentiality and act ethically. Perhaps most importantly, whereas community members may have some knowledge of different languages, unlike professionals, they are not trained to accurately render content and meaning between languages without bias and with appropriate cultural sensitivity. They almost certainly lack the specialty vocabulary and background knowledge required to comprehend and convey the complex medical and scientific content found in the clinical trial and biomedical research space and do so at the appropriate level of language in a manner that is free of bias and errors. While this is always crucial, it is especially vital to maintain compliance during informed consent.
Cultural generalization vs cultural bias
When engaging with individuals and groups of different cultural backgrounds, it is also important to bring cultural sensitivity and humility. Cultural generalizations or stereotypes could be unhelpful (i.e., the assumption that all people from a given cultural background will feel or behave in a certain way). Cultural bias – the propensity to interpret behaviors based on the norms of one’s culture – is also problematic, as it can lead to misunderstanding and, in clinical trials, diminish data quality and lead to inaccurate assessments.
The path forward
Overall, experts agree that requiring sponsors to submit DAPs is an important step toward greater diversity in clinical trials. Hopefully, these developments will push sponsors worldwide to work toward achieving diversity as the norm rather than the exception.
When you partner with a proficient, well-regarded language service provider, you gain a key ally in successful community engagement and improved recruitment. This partnership approach ensures that your communication is clear, unbiased, and compliant, with localization efforts tailored to your cultural and linguistic needs. Only by carefully navigating the waters of language and culture will it be possible to truly make progress on minority enrollment in clinical trials and, by extension, the diversity we so desperately need when it comes to diversity action plans.
By working with an experienced language service provider like Vistatec, our partners pave the way to success in biomedical research and inclusion.