Diversity in clinical trials is essential to ensure that study findings are generalizable and relevant to the populations they aim to serve. Understanding how a drug or vaccine may work—or cause side effects—differently across various groups is crucial for advancing equitable and effective healthcare.
In this blog post, we'll examine cultural competence and cultural humility—two complementary concepts that enable researchers and stakeholders to engage effectively with participants from diverse cultural backgrounds.
By embracing these approaches, clinical trials can achieve greater inclusivity and relevance, ultimately enhancing their success.
Cultural Competence and Cultural Humility
Creating an inclusive and equitable clinical trial environment goes beyond simply recruiting a diverse participant pool. It also requires an ongoing commitment to understanding and respecting different cultural perspectives.
Two key approaches that support this goal are cultural competence and cultural humility. While these concepts are distinct, they work together to foster meaningful engagement with diverse populations, ensuring that trials are conducted in a way that is both scientifically rigorous and culturally responsive.
Cultural Competence
Cultural competence encompasses the knowledge, skills, attitudes, and awareness needed to interact effectively with individuals from diverse cultural backgrounds.1
Within the context of clinical trials, cultural competence enables stakeholders to deliver research-related services in ways that are culturally sensitive, scientifically sound, and appropriately localized.1-2
Cultural Humility
Cultural humility is a lifelong process of self-reflection, openness, and acknowledgment of one’s own cultural biases.3-4 Cultural humility within the context of clinical trials emphasizes building equitable relationships with participants and fostering a commitment to ongoing learning.2
While cultural competence provides a foundational understanding of cultural practices, it may not fully address the unique, context-specific needs of individuals or communities. Cultural humility complements competence by emphasizing relational and reflexive practices that promote trust, mutual respect, and ethical engagement.5
Key Applications of Cultural Competence and Humility in Clinical Trials
- Protocol Design: Incorporating cultural insights to address barriers to participation and ensure relevance to diverse populations.
- Recruitment and Consent: Using culturally sensitive language and approaches to build trust and encourage participation.
- Implementation and Oversight: Ensuring that study procedures are adaptable to participants’ cultural needs, such as scheduling flexibility or accommodating language preferences.
- Data Interpretation: Contextualizing findings to avoid misrepresentation or bias and ensuring they are meaningful across diverse groups.
Beyond Patient Experience
Cultural competence and cultural humility extend beyond interactions with study participants to encompass all relationships involved in clinical trials and study-related services.
These approaches are critical in building trusting relationships, fostering collaboration, and ensuring the effectiveness of processes across diverse stakeholders. Below, we highlight an example showcasing their importance and impact on site interactions.
Data Quality Monitoring
At Signant Health, we deliver robust quality monitoring services for clinical outcome assessment (COA) data to ensure consistency in administration and scoring. A key element of this process involves identifying discrepancies and guiding site investigators to align with standardized scale guidance.
Cultural Nuances in Feedback Delivery
One critical consideration is the cultural nuances influencing how feedback is perceived and received. While constructive feedback is often encouraged and embraced in many Western cultures, it may not be as readily accepted in some Asian cultures due to deeply rooted social norms. For instance, many Asian societies prioritize preserving dignity and avoiding embarrassment for both the giver and receiver of feedback. Feedback perceived as overly critical or negative can lead to a “loss of face,” leaving the recipient feeling humiliated or undermined.
Hierarchical structures prevalent in many Asian cultures further amplify these challenges. Critiquing or questioning a superior, such as a principal investigator, can be viewed as disrespectful. Consequently, site investigators who are unaccustomed to receiving constructive feedback may interpret it as a personal failure rather than as an opportunity for growth and improvement. This perception can hinder the acceptance and implementation of feedback, undermining the remediation process.
Adapting Feedback to Cultural Contexts
Effective remediation requires adapting feedback to align with cultural norms. In high-context cultures, such as those in much of Asia, communication often relies on non-verbal cues, subtlety, and context rather than explicit verbalization. Feedback delivered in a direct and unvarnished manner, as is common in Western cultures, may be perceived as overly blunt or even offensive. Instead, feedback must often be softened or framed indirectly to maintain politeness and preserve relationships.
For example, suggestions for improvement might be framed within broader positive remarks or delivered in a way that allows the recipient to save face. An approach that acknowledges and respects these cultural preferences can significantly enhance the acceptance and effectiveness of feedback. In some cases, feedback is provided to a site monitor first, who then relays the message to the investigator in an appropriate manner.
Ensuring Effective Remediation
Failing to consider cultural factors during the remediation process risks rendering the efforts ineffective or counterproductive. It may erode trust, damage relationships, and hinder collaboration with site investigators. To address these challenges, Signant Health employs local clinicians who possess deep cultural knowledge and understand the specific nuances of their regions. These experts facilitate culturally appropriate feedback delivery, ensuring that communication is both respectful and impactful.
Building trust is paramount in these interactions. By creating an environment where site investigators feel supported rather than judged, remediation efforts become opportunities for meaningful dialogue and collaboration. This trust-based approach ensures that feedback is not only heard but also acted upon, leading to improved adherence to scale guidance and enhanced data quality.
Conclusion
Cultural competence and cultural humility provide a framework for inclusive, patient-centered, and ethical clinical trials. Incorporating these principles into every stage of the clinical trial process—from design and recruitment to implementation and data interpretation—can significantly improve participant experiences, enhance retention, and ensure that findings are meaningful across diverse populations.
About the author
Sayaka Machizawa, Psy.D., is an Associate Director of Clinical Science at Signant Health, bringing over 18 years of expertise in neurodegenerative and psychiatric diseases. She has played a key role in supporting large-scale global clinical trials across a wide range of indications. Fluent in both Japanese and English, Sayaka has led rater training sessions at numerous Investigator Meetings worldwide.
With a Doctorate in Clinical Psychology, she has also dedicated 12 years to academia, teaching graduate-level Psychology courses, and conducting neuropsychological evaluations for diverse populations. Her extensive experience bridges clinical research, education, and applied neuropsychology, making her a valuable contributor to advancing scientific rigor in clinical trials.
References
- Betancourt, J. R., Green, A. R., Carrillo, J. E., & Owusu Ananeh-Firempong, O. (2003). Defining cultural competence: A practical framework for addressing racial/ethnic disparities in health and health care. Public Health Reports, 118(4), 293-302. https://doi.org/10.1093/phr/118.4.293
- Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (n.d.). Cultural Considerations in Clinical Research. Retrieved January 14, 2025, from https://mrctcenter.org/health-literacy/tools/overview/cultural-considerations/#cultural1
- Foronda, C., Baptiste, D.-L., Reinholdt, M. M., & Ousman, K. (2016). Cultural humility: A concept analysis. Journal of Transcultural Nursing, 27(3), 210-217. https://doi.org/10.1177/1043659615592677
- Tervalon, M., & Murray-García, J. (1998). Cultural humility versus cultural competence: A critical distinction in defining physician training outcomes in multicultural education. Journal of Health Care for the Poor and Underserved, 9(2), 117-125. https://doi.org/10.1353/hpu.2010.0233
- Yeager, K. A., & Bauer-Wu, S. (2013). Cultural humility: Essential foundation for clinical researchers. Applied Nursing Research, 26(4), 251-256. https://doi.org/10.1016/j.apnr.2013.06.008