Building health equity: How can we mitigate barriers to diverse clinical trial participation?

As the industry increasingly recognises the need to address health disparities among communities that have been previously underrepresented in medical research, diversity and equality have become key priorities in the medical world. Of course, this is a progressive stride towards achieving health equity, but as industry professionals, we must ask ourselves: are we doing enough to mitigate the continued lack of diversity in clinical trials?

Acknowledging the ongoing problem

The marginalisation of groups in clinical trials is not just a historical issue—it remains a persistent problem in pharma and healthcare.

Although the inclusion of women in clinical research has risen since the 1990s, a lack of gender diversity is still evident in various therapy areas, such as psychiatry. (1) Despite women accounting for 60% of patients in psychiatric settings, a study covering 1,433 Phase 1-3 clinical trials conducted from 2016 to 2019 found that only 42% of participants were female. (2)

Furthermore, people of colour continue to be disproportionately underrepresented in clinical trials. In the US Food and Drug Administration 2020 drug trials snapshots summary, selected subpopulation demographics were reported from the trials of 53 newly approved drugs. It was noted that only 25% of the total 32,000 participants were of diverse racial and ethnic descent, with 11% being Hispanic, 8% Black or African American, and 6% Asian, while the other 75% of trial participants were White. (3)

It is important to note that ongoing gaps in clinical trial diversity extend beyond gender and ethnicity, with considerable exclusion of patients due to their age, sexual orientation, geographic location, and socioeconomic status, just to name a few.

The underrepresentation of certain populations in healthcare research directly impacts health equity, defined by the World Health Organization as “the absence of unfair, avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically or by other dimensions of inequality”. (4) Novel treatments developed in inadequately represented cohorts may be less effective or induce contrasting adverse effects in underserved patient groups. Consequently, the pharmaceutical industry cannot provide all individuals with the personalised care necessary for achieving optimal health and wellbeing, compromising universal health equity.

Key barriers to diverse clinical trial participation

So, what are the key barriers that influence the participation of underrepresented communities and result in poor clinical trial diversity?

There is a clear lack of awareness among patients regarding what clinical trials entail, and their value, for both the individual and the wider population. Unfamiliarity with clinical research may lead to fear and stigma around participating, leading to a sense of mistrust among patients. (5-6) Often, this lack of awareness and trust stems from insufficient educational resources for patients, and even physicians, within underrepresented groups. (7)

Moreover, participating in clinical research requires time and can be costly. Geographically isolated individuals, those with limited mobility, or people with a lower socioeconomic status may be unable to participate in trials, even if they are inclined to do so. Similarly, cultural factors such as language and beliefs may hinder clinical trial involvement. (7)

Mitigating barriers to advance health equity

Beyond raising awareness of the ongoing challenges, medical communications can be powerful in identifying and implementing tangible, scalable solutions to promote health equity for all.

At Synthesis, with our expertise in patient advocacy and representative patient engagement, we can support inclusive clinical trial participation through three principal strategies: (5-7)

1. Diverse patient engagement: We reach underrepresented communities by collaborating with local advocacy and patient groups in diverse regions to increase awareness of clinical trial opportunities and build trust among patients, while reducing fears about participation.

2. Communicate unmet patient needs: We regularly collect insights from underserved patients and disseminate these insights across the industry to raise awareness of unmet needs.

3. Patient materials: We develop lay-friendly, culturally appropriate educational materials tailored to diverse audiences to improve their understanding of clinical trials and enhance recruitment, whilst ensuring clarity and conciseness to improve accessibility.

Collaborating across the industry at both strategic and practical levels to shape healthcare policy is critical to addressing additional challenges faced by underrepresented groups in clinical research.

Our team of specialist medical writers at Synthesis Health is committed to promoting collaboration between pharmaceutical companies and stakeholders to drive systematic change for all by circulating diverse patient insights and learnings throughout the industry.

Please contact us at info@synthesishealth.co.uk to learn more about how we can support your patient engagement activities.

References

1. National Institutes of Health. (1993). NIH Revitalization Act of 1993 Public Law 103-43

2. Sosinsky AZ, Rich-Edwards JW, Wiley A, Wright K, Spagnolo PA, Joffe H. Enrollment of female participants in United States drug and device phase 1-3 clinical trials between 2016 and 2019. Contemp Clin Trials. 2022;115:106718. doi:10.1016/j.cct.2022.106718

3. US Food and Drug Administration Drug Trials Snapshots Report (2020) https://www.fda.gov/media/145718/download?attachment

4. Health equity, World Health Organization https://www.who.int/health-topics/health-equity#tab=tab_1

5. Clark LT, Watkins L, Piña IL, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers [published correction appears in Curr Probl Cardiol. 2021 Mar;46(3):100647. doi: 10.1016/j.cpcardiol.2020.100647]. Curr Probl Cardiol. 2019;44(5):148-172. doi:10.1016/j.cpcardiol.2018.11.002

6. Bae AS. Key barriers against racial and ethnic minority participation in U.S. clinical trials. Int J Clin Trials 2022;9(3):227-33

7. Building Health Equity By Minimizing Barriers To Clinical Trial Participation https://www.clinicalleader.com/doc/building-health-equity-by-minimizing-barriers-to-clinical-trial-participation-0001