Five Building Blocks to Achieving Diversity, Equity, and Inclusion in Clinical Research
Maimah Karmo
Tigerlily Foundation
Amy Sitnick
Del Smith
Stephen Walker
CSL Behring
Kate Wilson

linical trials rely on volunteers, and it’s important that they come from diverse backgrounds. However, it’s been documented that 85% of those who participate in clinical research are Caucasian.

While the desire to increase diversity in clinical trials isn’t new, the industry has renewed its commitment to make a difference. In fact, 84% of sponsors and CROs who responded to a recent Greenphire survey said that to “increase diversity of underrepresented populations (including ethnicity, socioeconomic, urban/rural, gender and more) among clinical trial participants” is a goal.

In a panel discussion at DIA’s Advancing Diversity, Equity, and Inclusion Across Life Sciences R&D meeting, industry experts discussed strategies for improving diverse trial engagement and highlighted the following tactics which can arguably improve study diversity and inclusivity throughout the clinical trial lifecycle.

1. Start by Building Trust with Diverse Communities

Lack of trust is not only one of the most significant challenges to broad-based access to quality healthcare but also a challenge to research participation in particular. Historical wrongdoings have instilled fear and skepticism regarding clinical trials. While much has been done to ensure that research is ethical and protects participants’ rights, building trust starts with building relationships.

  • Address health equity throughout the spectrum of care and not just during a clinical trial. At least one organization advocates that sponsors have a presence in diverse communities both before studies start and after they end; don’t go to these communities only when you need them.
  • Identify “activation points” to build credibility and the ability to scale relationships with communities of color. These may be elected officials, healthcare providers, faith-based organizations, sororities/fraternities, to name a few. Position your organization as committed not just to the therapy being studied but also to providing preventative care such as blood pressure screenings.

In many communities, sports coaches are significant activation points not just for their players but for the players’ families, too. They can help encourage thinking proactively about healthy living and innovative treatments.

2. Make Your Study Design Inclusive from the Start

In 2020, the FDA issued guidance to enhance the diversity of clinical trial populations, an important first step toward increasing enrollment of underrepresented populations. These recommendations suggest inclusive trial practices such as broadening eligibility criteria and recruitment and retention practices, and more inclusive trial designs.

Diverse patient advocacy matters. Early engagement of diverse voices can help shape drug development protocols so they recognize and anticipate obstacles, and alternative solutions, before they are formally approved. The Tigerlily ANGEL Advocacy Program trains young women to not only advocate for self-care but to roll out Angel Advocacy Cohorts with sponsors to inform future study designs in cities with the highest mortality rates for Black women, so that there is representation and opportunity to co-create throughout every stage of the community, healthcare, clinical trial, and policy continuum.

  • Reassess the study wording. For example, some wording has isolated Black and brown communities in particular. By reconsidering words such as protocol (“plan for the study”), investigator (“person or doctor in charge of the study”), and trial (“study or research”), study participation can be made more accessible and welcoming to all.
  • Diverse site availability. Sponsors should work to ensure that clinical trial sites are not only placed in geographic locations with higher concentrations of racial and ethnic minority populations, but also locations within neighborhoods where these populations go for everyday healthcare.
  • Cross-promote clinical trials with other services, such as plasma donation centers. Communicating the benefit of clinical trials in the context of other community health services can make trials seem more accessible to the public.
  • Recent research from CISCRP confirms that not just site location but also the ethnicity of site staff can hold the key to improving diversity in trials. Bringing more diverse personnel into the clinical research profession should enable sites to more effectively recruit and retain more diverse participants.
Maimah Karmo leads education and advocacy efforts through her work at the Tigerlily Foundation. For her, this work is personal. Having overcome the unlikely odds as a young woman with triple negative breast cancer, her goal is to educate young women, through digital channels such as social media and partnerships with pharmaceutical companies and pharmacies, before they get cancer, and, most importantly, to build relationships and invest in communities and the people who live in them to create sustainable change.

The Tigerlily Foundation works to ensure that information is distributed regarding the importance of living a healthy lifestyle, being proactive about health, knowing how to reduce risks, and overcome barriers to health equity. Karmo believes that we owe it to the future to create measurable, specific, actionable, timely change—with accountability.

“Everybody who is touching the patient along the entire continuum has the opportunity to embrace that patient and transform their healthcare experience. Listen, lean in, and learn from the patient. You’ve taken an oath to protect your patient, and that means listening to them, learning from their experiences, and asking them what they need to feel safe with you.” –Maimah Karmo

3. Quantify Efforts and Report Results Widely

In 2022, FDA published additional guidance to help improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials and advocated for the submission of Race and Ethnicity Diversity Plans. This guidance is particularly important because it calls for establishing specific plans and goals for increasing diverse participant enrollment.

In response, one organization’s dedicated effort to improve diverse enrollment and access to clinical trials includes creating a standing Community Advisory Board to build bridges between the company and communities who have encountered gaps in education and awareness, along with establishing smart goals and measures for tracking trial diversity.

This organization establishes specific race and ethnicity recruitment goals based on the epidemiology of the disease being studied, to ensure the study population represents the intended treatment population, for every clinical trial they conduct in the US. An internal dashboard tracks and measures the demographic distribution of US participants across programs and studies and directly compares these measures to epidemiology targets. This dashboard is reviewed monthly and then shared upward with senior management. Additionally, diverse and representative study recruitment goals are tied to the company’s corporate health equity strategy and goals, building transparency and accountability of this commitment across the entire organization.

4. Make It Easier for Participants to Find and Sign Up for Clinical Trials

Despite awareness and recruitment efforts by pharmaceutical companies and research sites, clinical trials remain lesser-known treatment options for the public. However, the COVID-19 pandemic raised awareness of clinical research, especially by those who historically may have been underrepresented. For example, 73% of respondents in the 2021 CISCRP Perceptions and Insights 2021 Study said that the pandemic had increased their awareness of clinical research studies. Hispanic respondents were more likely to report “greatly increased awareness” compared to non-Hispanic counterparts, and Black respondents were more likely to report “greatly increased awareness” compared to white and Asian respondents.

Still, more work is needed to raise awareness and make clinical trials more widely available.

  • Our observations and experiences strongly suggest that is not user-friendly. One company has taken steps to make finding clinical trials simpler, regardless of sponsor, by partnering with myTomorrows to help patients and their families access clinical trial resources and offering the ability to speak with a medically trained professional.
  • Another company has introduced the NowIncluded platform, designed to be a framework for diverse communities to share content about preventative care, clinical research, and other health topics. Through this app- and web-based portal, minority communities can express their concerns and learn more about their healthcare options.

5. Make Trial Participation Less Burdensome for Participants

One more barrier to clinical trial participation is that clinical trials have become increasingly complex and time-intensive for study participants. FDA’s 2020 guidance lays out several improvement recommendations.

For example, FDA suggests that participants be made aware during recruitment of any potential financial costs and reimbursements. This CISCRP brochure can help communicate this to participants. Nonetheless, time away from work, parking, tolls, and other expenses can take a financial toll. Not surprisingly, being “reimbursed for any out-of-pocket expenses” was ranked highly in the 2021 CISCRP Perceptions and Insights Study as a means to improve retention.

This study also confirmed that all potential study participants, including Hispanic and Black responders, prefer digital patient engagement. In fact, both groups said the following were “very important,” compared to non-Hispanic/white subgroups:

  • Mobile app availability
  • Information specific for caregivers
  • The ability to review and sign documents in an electronic format
  • Some or all visits conducted remotely/virtually at the home/office

Simple solutions can help improve access and drive diverse participation. For example, offering the flexibility of remote visits through decentralized trial technology can remove geographic barriers to site recruitment and enable individuals who may be constrained by work obligations to not have to physically visit the clinic at all.

The Time Is Now: Diversity Is Paramount for Clinical Trials

In the 2021 CISCRP Perceptions and Insights Study, 97% of respondents said that “it is important/somewhat important for clinical research studies to include a diverse group of participants to better reflect the patients who will end up using the therapies once they are approved by a regulatory agency.”

Let’s commit to pilot change in clinical trials and make the treatments of the future safer and more effective for everyone. Everyone!