Tackling barriers to diversity, equity, and inclusion in clinical trials

As we enter our third year of the COVID-19 pandemic, stark health inequalities continue to expand globally. In particular, vulnerable, marginalized, and minority communities – including racial/ethnic minorities, LGBTQIA+ individuals, women, children, adolescents, older adults, people with disabilities, migrants, refugees, and those living in rural areas – are faced with greater socioeconomic and health disparity. This includes less security in terms of food, home, education, and employment, combined with greater COVID-19 risk and poorer access to healthcare, which in turn contributes to the widening inequality gap and places considerable demand on public health systems. While tackling these issues requires a multisectoral and multinational approach, we at Clariness reflect on our role in solving the current crisis and how to overcome challenges towards improving health equity through access to new treatments.

With our Mission “to improve patients’ lives by accelerating the development of new medical therapies,” we aim to break down barriers to patient recruitment and boost the inclusion of underrepresented communities in clinical trials through thoughtful engagement with patients, their communities, and other clinical trial stakeholders.

COVID-19 and the necessity of health equity

While COVID-19 intensified inequalities, it also highlighted the foundational role that health plays in stabilizing our societies. As Elliot Harris (UN Assistant Secretary-General for Economic Development) warns, “If we don’t act now, the entrenched inequalities that are already there will worsen… there is a greater awareness that this inequality is having consequences and [causing] social upheavals.” In fact, the negative consequences of the pandemic, particularly on minority communities, have already shaped and spurred recent movements, such as Black Lives Matter and Stop AAPI (Asian American Pacific Islander) Hate. Still, there is a long way to go until we reach an equitable society as we continue to see how communities within and across borders are unequally impacted. For example, in the US, Black/African American, Hispanic/Latino, and Indigenous communities experienced disproportionately higher rates of COVID-19-related hospitalizations and deaths. Explanations for these disparities include systemic racism and discrimination, compounded by worse access to healthcare, high-risk (less flexible) occupations, and more crowded housing conditions in comparison to non-Hispanic white people. Worldwide, as countries in the Global North begin to recover, developing countries continue to struggle as overrun healthcare infrastructures and fewer resources continue to hinder efforts towards economic recovery.

Although the innovative and rapid development of COVID-19 vaccines is hailed as “a triumph of science and collaboration,” large inequalities during vaccine clinical trials soon became apparent as racial/ethnic minorities were underrepresented in these trials. Additionally, many scientists (including Dr. Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases) argued that these patients should be overrepresented in vaccine trials to reflect their disproportionate burden and to ensure safety and efficacy of vaccines in all patients. In response, the US Federal Drug Administration (FDA) issued recommendations in June 2020 encouraging the “enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities.”

Seeing difficulties in finding the right patients for COVID-19 trials, Clariness offered intensified support to overcome challenges by helping connect qualified patients to sites. Specifically, we included strategies to maximize outreach to Black/African American and Latino/Hispanic communities by increasing clinical trial awareness, using more representative images, translating materials into Spanish, and supporting patients through the screening and enrollment processes (reducing both patient and site burden and speeding up recruitment timelines). To better understand how patients were affected by the pandemic, we also performed a global patient insight survey on patient well-being and trial participation (with >17,000 patients from 21 countries responding).

As the number of clinical trials continues to grow, study populations still fail to reflect real-world patient populations – despite known risks in doing so. In a recent analysis of >290,000 global clinical trial participants, 76% were white, 11% Asian, 7% Black, and 6% other; in contrast, 60% of the global population is Asian, 16% African, 10% European, 7% Latin American, and 7% other. Regarding COVID-19 vaccine trials, although trials held by Pfizer-BioNTech and Moderna showed greater diversity than previous clinical trials, certain racial/ethnic minorities are still underrepresented – particularly Black/African American participants. This lack of diversity limits our knowledge on the generalizability of treatments as studies show that some medicines work differently among various patient groups. For COVID-19 vaccines, research suggests that vaccine responses may vary based on the patient’s race/ethnicity and age, with another study suggesting decreased vaccine efficacy in individuals with Black/African or Asian ancestry. Other studies also show sex differences, with women having more side effects and adverse reactions (e.g., changes in menstruation, blood clots). However, despite the equal representation of women and men in COVID-19 clinical trials, only 12 out of 35 studies (or 34%) reported safety data by sex/gender.

To address these concerns, several regulatory bodies and other clinical trial stakeholders are pushing for patient-centric approaches to improve diversity, equity, and inclusion (DEI) in clinical trials. These include the recent FDA guidance documents on “Enhancing the Diversity of Clinical Trial Populations” and “Collection of Race and Ethnicity Data in Clinical Trials”; the NIH policy for the “Inclusion of Women and Minorities” in NIH-funded research; and the European Association of Science Editors’ “Sex and Gender Equity in Research Guidelines.” More recently during the COVID-19 pandemic, new guidelines were released by the FDA and EMA allowing sponsors to adapt clinical trial protocols to include decentralized methods (e.g., telehealth, remote patient monitoring) that reinforced social distancing and safety of patients and site teams. Although decentralized or hybrid clinical trials can improve patient recruitment and retention in general, it has a specific impact on improving patient diversity in clinical trials by addressing barriers underrepresented populations often face (e.g., live far away from sites, non-flexible working schedules) – making trials more accessible. However, certain patients (e.g., older adults, patients with disabilities) in these trials will also require additional support (e.g., navigating new technologies, self-administering certain medications) – emphasizing the necessity of researching and understanding specific patient needs and applying these to study designs.

Now, with 10 billion doses of COVID vaccines delivered to 4.8 billion people (>60% of the world population) in record-breaking time, “scientists warn that woeful inequalities in access remain.” Within countries, large gaps exist between different communities (particularly affecting non-affluent and/or non-Hispanic white people), with even greater inequalities between countries. With rollouts of vaccines beginning in late 2020 and early 2021, only 5.5.% of people living in low-income countries have received 2 doses – compared to high- and middle-income countries that have already begun to deliver third (or fourth) doses of booster shots (accounting for one-third of all COVID-19 vaccine doses given daily worldwide). With less (or zero) vaccine availability in developing countries, this only continues to slow down recovery and increases the risk of emerging variants from unvaccinated populations:

Across all of Africa, only 16% of the population have received one COVID-19 vaccine dose, with Mosoka Fallah (founder of Refuge Place International in Bassa Town, Liberia) stating, “As an African, the real significance of reaching ten billion vaccines administered is the extreme inequity that exists in vaccine distribution between the global north and global south…Until we correct this inequity, the world will continue to see new variants.”

As Joseph Stiglitz (Nobel economist and professor at Columbia University) points out, “The pandemic won’t be controlled until it is controlled everywhere.” And the same applies to achieving health equity – we cannot achieve health equity until each individual has a fair opportunity to be healthy, which requires taking care of those who are most vulnerable and ensuring they have access to safe and effective treatments.

Our approaches: Patient outreach and amplifying the patient’s voice

As a patient recruitment company, patients are at the heart of everything we do. With 16+ years of experience supporting 1,200+ clinical studies in over 50 countries, we continually adapt our services to the needs of the patients. Our patient-centric approaches to patient recruitment that can be applied directly to DEI include:

Even after enrollment, clinical trials face issues with patient adherence to treatments and retention, reducing statistical power to determine efficacy of treatments that may bias trial conclusions. Besides lower enrollment in clinical trials, racial/ethnic minorities, as well as older patients, patients with language barriers, patients with disabilities, and patients in rural areas are also more likely to drop out and be Lost-to-Follow-Up. By applying an intersectionality framework and gathering patient insights to better understand who patients are, we can work towards tackling specific barriers patients face to improve health access and care for those who need it most.

Our outlook for the next year – what we aim to achieve

We as an industry need to ensure that all patients have fair access to safe and effective therapies – which means the inclusion of underrepresented communities not just within, but across, borders in clinical trials. Following recent social movements – along with the COVID-19 pandemic exacerbating inequalities – there is now an increasing call to action for clinical trial stakeholders (e.g., sponsors, regulatory bodies, patient groups, research institutes) to tackle diversity, equity, and inclusion in healthcare. However, we can only realize this through the combined actions of public health policies and programs (e.g., diversity initiatives); implementing structural changes (e.g., hiring more diverse investigators and clinical staff); adapting study designs (e.g., decentralized methods); improving health literacy (e.g., accessible medical and study information) and communication (e.g., local languages); rebuilding trust (e.g., transparency); and being aware of how individual backgrounds shape trial interest, recruitment, and retention (e.g., patient insights, cultural competency training).4-steps-DEIIn response to these growing social and health issues, we will present a series of blogs in the upcoming year on DEI in clinical trials by analyzing current challenges and developing solutions. We intend to play a key role in improving health equity through collaborations and applying research into action to help patients get quicker access to the safe and effective treatments they need. If you have any questions on how to improve DEI in your clinical trials – or if you are a patient advocacy group, patient organization, or industry leader who would like to partner with us – please contact us here. You can also learn more about our patient-centric methods to DEI on our Patient Diversity page.

Let’s work together to achieve diversity, equity, and inclusion in clinical trials.

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