Implementing Inclusivity: Putting Clinical Trial Equity Into Practice

The research industry’s approach to building clinical trial equity and inclusion has shifted, bringing a renewed focus to these goals. This is great news: Trials that more accurately represent patient populations yield more robust results, and when there are fewer barriers to participation, trials can recruit more participants. 

Nearly everyone is on board with this cultural shift toward more inclusive research, but how can we translate these ideas into practice? The future of equity in clinical trials relies on concrete action. Now that the industry has moved toward a shared understanding of the big picture, the next step is commitment to a detailed plan to make this vision a reality. This involves identifying barriers and creating targeted strategies to overcome them. 

Defining the key concepts

Defining equity, inclusivity, and diversity is about more than just semantics; it is central to understanding how we can level the playing field to ensure everyone can be included in research: 

• Equity refers to providing individuals with the specific resources they need and access to opportunities; this differs from equality, which is offering the same resources to everyone, regardless of their unique circumstances
• Inclusivity is the practice of creating environments where all individuals feel welcome and valued, especially those who might otherwise be excluded or marginalized
• Diversity is the presence of a wide range of human differences. Race and ethnicity are often a major focus, but diversity also includes geography, socioeconomic status, gender, disability, language, and a wide variety of other factors. Across the full spectrum of diversity, these factors act as social determinants of health and are therefore essential to consider in clinical research 

All these elements build on one another. Trials that are more equitable allow for more inclusive and diverse participation, and thinking about how to boost inclusivity requires an understanding of equity. 

To put these concepts into practice: 

• Conduct community assessments to understand the specific needs and barriers faced by different populations
• Develop tailored recruitment strategies that address these barriers, such as providing transportation, or flexible visit options
• Engage with local leaders and community organizations to build trust and increase awareness about clinical trials

Why diversity matters — and why now? 

Diversity in clinical trials is crucial because it enhances the effectiveness, safety, and representativeness of medical therapies. When trial participants reflect the demographic variability of those who will use the treatments, researchers can more accurately assess how these therapies work across different groups. This diversity is essential not only for determining the efficacy of a treatment but also for understanding the treatment’s safety profiles, which may vary among different ethnicities, ages, and genders. Without this breadth of data, certain populations may face higher risks because their physiological responses were not adequately represented during the trials, and therefore not understood.

The presence of diversity in clinical trials also builds trust among the broader population. When people see results from clinical trials that include individuals like themselves, they are more likely to believe that the results are relevant and that the therapies are safe and effective for them. In one 2023 study, results from a more representative trial increased confidence in the likelihood of the studied drug working by 20%. This trust is crucial not only for patient confidence but also for physicians and other healthcare providers who rely on these results to make informed treatment decisions. 

The FDA’s diversity plan guidance highlights the importance of these efforts as part of a broader cultural shift toward more equitable healthcare research, and has brought these efforts to the forefront. The question now is how the FDA will work going forward to implement these diversity plans. 

Think global, act local

Translating the ideals of equity, inclusivity, and diversity into actionable strategies requires a detailed, localized approach. To effectively implement these concepts, organizations must deeply consider the specific needs and circumstances of the communities they aim to serve. This means understanding not just the demographic and health profiles of the patient populations, but also the nuances of how healthcare is delivered and accessed on a local level. It involves identifying potential barriers to participation and crafting tailored strategies to overcome these obstacles. Engaging with community leaders and institutions to build trust and learn from their insights is essential for this process.

“Choice” is a major consideration for equity in research. There are always going to be traditional clinical trial sites with established patient bases who trust those healthcare providers, and this is a great, consistent avenue for driving participation. However, it does not work for every patient or every community. Adding more options for people, such as mobile research units, home-based trials, telemedicine visits, and the like will help us engage with a broader range of individuals from diverse backgrounds and ensure their voices are represented in research — while traditional sites remain as an option for those who can access and may prefer them. 

Steps to enhance inclusion: 

• Deploy mobile research units to bring clinical trials directly to underserved communities, reducing travel barriers
• Implement telemedicine visits to provide flexibility for participants who cannot easily visit traditional sites
• Offer home-based options where study visits can be conducted in the participant’s home by trained healthcare professionals
• Provide multilingual resources and translations to ensure non-English speakers can fully participate and understand the trial procedures

Diversity and inclusion also extend to clinical teams. Having more representative staff helps build trust among participants; psychologically, the more similar we feel to others, the more likely we are to trust them. Engaging research naïve sites and new investigators who work in underrepresented populations is one way to advance this idea. This requires ongoing support and training tailored to the investigator and site’s specific needs. 

Considering which choices to offer, and what training or resources may be necessary, goes back to equity and a thorough understanding of the community with which you are engaging. This is especially true when it comes to technology. Giving everyone the same technology to participate in a trial will not yield the same results, and patients can face barriers ranging from limited internet connectivity to a lack of familiarity. Building a trial that is accessible is part of inclusivity, so considering these questions early is a must. 

Planning to take risks safely 

Diversity, equity, and inclusion can’t simply be tacked onto your trial protocol and plan. Ideally, you should be proactively planning six months to a year in advance to give time to engage with relevant communities. This is also when you should engage with your institutional review board (IRB) and compliance professionals to ensure regulatory needs are considered. This kind of approach does not need to be expensive, so long as it is thoughtful and allows time for thorough planning. 

The clinical research industry is — for good reason — averse to risks. However, trying new approaches is essential for progress. In the realm of inclusivity and equity, planning early and engaging key stakeholders throughout the process makes it possible to make these changes while also safeguarding participants. 

Actions for risk planning: 

• Start early engagement with communities and stakeholders to build trust and gather insights
• Collaborate with IRBs to ensure all regulatory requirements are met
• Develop a detailed risk management plan that includes contingency strategies for potential challenges

Photo: FotografiaBasica, Getty Images

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