Addressing implicit bias in clinical trials

There is known implicit bias in healthcare, which has been shown to influence treatment decisions, adherence and patient health outcomes[1]. Disparities in health outcomes can be identified across the world, with Black women in the United States over three times more likely to die as a result of pregnancy complications than their white counterparts[2], and older people from ethnic minority groups in the United Kingdom more likely to be suffering with multiple long-term conditions[3].

However, this bias does not exist only in communities of healthcare professionals (HCPs) – it can be found throughout the drug development process too. The lack of diversity in clinical research is a concerning issue and the debate on how best to improve diversity in clinical trials is not a new one.

While cultural competency was a good initial step, it is limited in a few ways. It’s outcome is static. People are either culturally competent, or they are not. This has led to HCPs who have completed such training to being falsely convinced that they are delivering care in a culturally competent manner, when in fact they aren’t. One study found that over 80% of HCPs often or sometimes found it more difficult to engage with or treat patients from cultures different from their own[4].  And, while 84% of HCPs agreed that disparities affect their practice, just 29% believed that personal biases influenced their level of care[5]. For this reason, cultural competency has been critiqued for amplifying the notion that HCPs can, and should, aim to master a certain level of knowledge about other cultures, and that in itself is enough to eliminate bias. Cultural competency has therefore become a tick-box exercise, rather than a solution.

Cultural safety is the next evolution as it has an element of introspection. It’s expected that by highlighting the importance of one’s own cultural identity, people are able to understand the value that patients place on their own cultures, too. HCPs are then encouraged to challenge how their cultural identity may impact the way they deliver care. This in itself remedies one of the problems with cultural competency. Whereas cultural competency enables ‘othering’ of cultures, cultural safety forces the focus to be on the culture of the HCP, and its consequent impact, rather than on the patient. Due to its reflective approach, cultural safety becomes more than a tick-box exercise, as it promotes an ongoing element of self-reflection on clinical practices.

Furthermore, cultural safety goes deeper than cultural competency, covering far more defining features of culture than just ethnicity. By encompassing more key elements, cultural safety enables a more inclusive approach to healthcare.

Fortunately, cultural safety approaches can be applied to clinical trial staff training, too. Whether the training is used to impact study and protocol design, improve patient recruitment activities, or enhance the patient experience – this ongoing practice works to improve diversity in clinical trials, which is imperative in improving healthcare for all.

References

1. Bryant, Z. and Saluja, B., 2021. How Implicit Bias Contributes to Racial Disparities in Maternal Morbidity and Mortality in the United States. Journal of Women’s Health, 30(2), pp. 270-273.
2. Hall et al., 2015. Racial/Ethnic Bias Among Health Care Professionals and Its Influence on Health Care Outcomes: A Systematic Review. American Journal of Public Health, 105(12), pp. 60-76.
3. Petersen et al., 2019. Racial/Ethnic Disparities in Pregnancy-Related Deaths – United States, 2007-2016. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 68(35), pp. 762-765.
4. Watkinson et al., 2021. Ethnic inequalities in health-related quality of life among older adults in England: secondary analysis of a national cross-sectional survey. The Lancet, 6(3), pp. 145-154.
5. Shepherd et al., 2019. The challenge of cultural competence in the workplace: perspectives of healthcare providers. BMC Health Services Research, Volume 19, p. 135.