Improving Diversity, Equity and Inclusion in Clinical Trials

Enhancing diversity, equity and inclusion (DEI) in clinical trial populations is a moral imperative. It has long been acknowledged that DEI is crucial for broadening the scope, creativity and innovativeness of medical research and bolsters success in solving complex problems whilst reducing inequities in health and disease.

There is a striking underrepresentation of minority racial and ethnic groups in clinical trial research. In the US, 40% of the population is composed of diverse ethnic and racial groups, however, 75% of the 32,000 participants across the 53 novel drugs trials conducted in 2020 by the US Food and Drug Administration, were White (1). Study populations for drug trials should reflect the diversity of the population the drug is being developed for, otherwise, the generalisability of the trial results is compromised. In the field of oncology, it could also lead to miscalculations of disease-free survival rates and erroneous estimates of treatment efficacy, which together could further exacerbate health disparities.

Some strategies to improve DEI in clinical trials are:

 

1) Broaden the eligibility criteria

There are many more patients available for trial enrollment than there are available slots. Each trial has specific criteria for patient enrollment e.g., cancer type and stage, biomarkers, prior treatment received and absence of comorbidities. As comorbidities are likely to increase with age, exclusion can impact age equity and more importantly the generalisability of results. The complexity of eligibility criteria has increased over time and more attention is being paid to the scientific rationale for common criteria. Broadening criteria in cancer trials to include metastases and other malignancies along with comorbidities allows for the inclusion of more women and older people providing equity with respect to age and sex (2).

 

2) Address the problems associated with socioeconomic status, cost and time

Those who participate in trials are more likely to be employed, have health insurance, and have higher incomes and wealth. Low socioeconomic status is associated with low trial participation. Hidden costs such as travel expenses to clinics, need for childcare and loss of income for work missed to attend appointments, will be more significant for those of lower socioeconomic status. Assessing socioeconomic demographic data will allow for the categorisation of populations to address how this affects people across races, ethnicities and ages in accessing clinical trials (3). Associated costs and time for participating in trials are more likely to affect the elderly, pregnant women and rural populations as most trial sites are in urban areas (4). Remuneration of participant costs is debated due to the possibility that it will bias decision-making and informed consent, however, addressing associated costs with participating in trials is necessary to diversify clinical research.

 

3) Cultural sensitivity

Language barriers present a big obstacle to recruiting minority ethnic groups to clinical trials. The trial research process must be communicated and explained fully and appropriately so that proper informed consent is given and to ensure participant understanding and comfort in taking part. Different ethnicities and cultures may have different health beliefs that affect their willingness to take part in clinical trials, therefore cultural sensitivity is required when approaching patients for enrollment.

 

4) Build trust in the medical community

Trust in the medical community is declining due to wasteful healthcare spending and the vastly reported consequences of medical errors in the media. Additionally, ethical breaches in clinical research are still on the public conscience. Past ethical breaches such as the Tuskegee experiment, where African Americans were infected with syphilis and administered placebos when penicillin was the recommended treatment, still impact on the hesitancy of African Americans to take part in clinical research. Another example that spurs medical mistrust is the ‘thalidomide babies’, who were born with serious defects after their mothers had been prescribed thalidomide for morning sickness. More recently, the COVID-19 pandemic highlighted significant disparities in mortality rates in Black, Asian and minority ethnic (BAME) groups compared to White people (5), which further exacerbated medical mistrust.

Prospective patients may also experience personal fears about taking experimental drugs with unknown side effects. The onus is on the medical community to address mistrust to facilitate better access to clinical trials.

 

5) Adjust for the education level of participants and improve health-literate practices

A barrier to enrollment can be a lack of awareness by patients around clinical trials. Increasing awareness and facilitating education on clinical research will make patients feel more informed and can impact their willingness to take part. When approaching patient for trial enrollment, their level of education needs to be considered as clinical trial information can be quite complex and is usually catered toward patients with high educational achievement (6). Additionally, language complexity and readability need to be appropriate given the primary language of the reader as well as the level of education (7). Increasing education around clinical trials could be facilitated by primary healthcare providers and/or trial sponsors. Improving health literacy practices will also address disparities and increase participant trust and enrollment. Clinical research is voluntary and participants have the right to understand the trial, it’s goals, risks and potential benefits. Clinical trial literature could be improved by including funders, sponsors, investigative study teams, potential participants and their families/caregivers in the development of health literature (8).

 

6) Promote diversity within the medical and research communities

The 2020 US census estimated that 33% of people identify as members of racial or ethnic groups that are underrepresented in medicine, yet when considering the diversity of research faculty, only 6% were members of such groups (6). Personnel diversity is correlated with patient enrollment diversity. Hiring and supporting investigative site personnel that best reflects the patient community will improve diversity in trial enrollment. This would additionally support better physician-patient relationships which is the foundation of clinical care.

 

References

1. US Food and Drug Administration. 2020 drug trials snapshot. Summary report.
2. Guerra, C.E., Fleury, M.E., Byatt, L.P., Lian, T. and Pierce, L., 2022. Strategies to advance equity in cancer clinical trials. American Society of Clinical Oncology Educational Book, 42, pp.127-137.
3. Kahn, J.M., Gray, D.M., Oliveri, J.M., Washington, C.M., DeGraffinreid, C.R. and Paskett, E.D., 2022. Strategies to improve diversity, equity, and inclusion in clinical trials. Cancer, 128(2), pp.216-221.
4. Allison, K., Patel, D. and Kaur, R., 2022. Assessing Multiple Factors Affecting Minority Participation in Clinical Trials: Development of the Clinical Trials Participation Barriers Survey. Cureus, 14(4).
5. Pepperrell, T., Rodgers, F., Tandon, P., Sarsfield, K., Pugh-Jones, M., Rashid, T. and Keestra, S., 2021. Making a COVID-19 vaccine that works for everyone: ensuring equity and inclusivity in clinical trials. Global Health Action, 14(1), p.1892309.
6. Boulware, L.E., Corbie, G., Aguilar-Gaxiola, S., Wilkins, C.H., Ruiz, R., Vitale, A. and Egede, L.E., 2022. Combating structural inequities—Diversity, equity, and inclusion in clinical and translational research. N Engl J Med, 386, pp.201-203.
7. Willis, A., Isaacs, T. and Khunti, K., 2021. Improving diversity in research and trial participation: the challenges of language. The Lancet Public Health, 6(7), pp.e445-e446.
8. National Academies of Sciences, Engineering, and Medicine, 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. National Academies Press.