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Establishing Strategies to Improve DE+I in Clinical Trials

Explore our Strategies to Improve Clinical Trials DEI eBook. Read an excerpt below or download the full eBook here.

Considering diversity, equity, and inclusion (DE+I) in clinical trial design and delivery is essential to properly measure treatment effectiveness and safety for therapies serving global patient populations. While the concept is nothing new to the clinical trial space and progress has certainly been made, increasing DE+I in clinical trials must remain an ongoing commitment for sponsors, clinical trial coordinators, and clinicians as well as community partners.  

As part of this continuous DE+I journey, sponsors must be intentional when designing clinical trials, identifying site locations, and establishing patient screening criteria to ensure that patient populations best represent those potentially eligible for their therapies. This would require equitable representation of races and ethnicities as well as individuals from differing socioeconomic backgrounds, sexual orientations, gender identities, neurodivergences, and physical disabilities in the overall population. 

History of DE+I and Clinical Trials

More than 80% of clinical trials are conducted in the developed world. The concentration of trial sites presents a problem for sponsors developing global therapies because developing countries represent the majority of the world’s population and bear 90% of the worldwide burden of disease. In the United States, clinical trial populations have consisted mostly of white males. Even today, African American patients, for example, represent less than 10% of clinical trial participants. This representation imbalance has been significant in contributing to health disparities in minority communities, as treatments are tailored to only a narrow subset of the population and impede the quality of healthcare decision-making and even the development of more effective treatments.  

As the industry turns its attention towards precision therapies, there’s a risk of continued exclusion and outcome disparity if trials aren’t designed with a broader view of recruitment factors. Considering race, ethnicity, sexual orientation, socioeconomic status, age, ancestry, and gender identity in clinical trials can yield broader inclusion and potentially new insights into drug efficacy. It also takes the industry one step closer to advancing health equity for historically underrepresented groups. Achieving health equity begins with each clinical sponsor and the actionable steps that they can take to expand DE+I in clinical trials. 

Download the Strategies to Improve Clinical Trials DEI eBook

Correcting Historical Health Inequities: Pre-Clinical Trials

Issues in past clinical trials, such as involuntary patient commitments and harmful management, have fostered distrust in many communities. These past issues still impact recruitment efforts and participation today as individuals choose not to opt into studies. There are steps that sponsors can take as they implement broader DE+I strategies for their trials:  

1. Leveraging Culturally Relevant Marketing 

One means of bridging distrust is by utilizing culturally relevant marketing. This might mean using language or imagery that connects with target communities in an authentic manner. A best practice for building this type of marketing is to work directly with members of the community to craft a message that will be fully embraced by the group. 

It’s also important to be aware of where marketing will be the most effective. Working with community leaders to understand certain places that are central to a group is key. Whether these are recreation centers, religious institutions, or local shops, being able to place marketing in culturally important locations can be a catalyst to opening dialogue.  

Ultimately, rebuilding trust in a community through marketing begins with awareness and is vital to help potential participants feel safe. When it comes to culturally relevant marketing, it’s important for organizations to know that this takes time, and developing these relationships with communities should occur before, during, and after the clinical trial process. 

2. Building the Patient Relationship 

It’s crucial for sponsors to be mindful of the need to establish strong clinician-patient trust. Recruiters should have an understanding of the local community, any common barriers to participation (e.g. site access and trust), and an ability to explain the purpose of the trial in the context of its potential benefit to the community. Often the best clinicians for target groups are those who are members of that group themselves. This is important because patients may feel more comfortable participating with those who have shared experiences, being honest throughout the trial, and voicing concerns they may have.   

A diverse clinical staff can also have insight into a culture that would otherwise be overlooked. This means recognizing, understanding, and addressing implicit biases that may skew patient interaction. Further, sponsors can partner with diverse clinical trial primary investigators (PIs) in addition to contract research organizations (CROs) with recruiting capabilities within diverse populations. These should be people that understand minority hesitancies and can effectively build trust through shared experience and educational programs. 

Additionally, removing language barriers is a critical factor in building relationships Those who do not speak the primary language used in the testing protocol as their native language may feel uncomfortable participating or hesitant to voice their concerns. Sponsors must be mindful of their clinical research teams’ backgrounds and demographics to ensure patients feel seen, represented, and heard. 

3. Educating Communities 

Issues of past unethical trials and ongoing experiences of bias in the delivery of care to marginalized communities are barriers to trust that sponsors will need to work to overcome. Broadly educating communities about the benefits of diversifying trials can begin to build a bridge of cooperation. Training recruiters to include messaging about how the study may positively impact the community to which a potential patient belongs may persuade them to participate and even advocate for the trial to others.   

DE+I in clinical trials has tangible benefits for treatment success. As more groups are represented, researchers are better able to understand how the treatment affects the broader population. Improving clinical trials begins with a sponsor’s awareness of making conscious choices to develop relationships within new communities, increasing the diversity of staff to expand thought and approaches, and working with the clinicians themselves in understanding the past and how to best approach different communities.  

Strategies to Improve Clinical Trials Design to Advance DE+I 

DE+I within clinical trials goes far beyond just including more diverse individuals in the trials themselves. Engaging underrepresented groups often means rethinking entire strategies for designing clinical trials. To achieve clinical trials that are more representative of the overall population, sponsors and clinical trial coordinators must partner together on efforts for site location and patient selection and recruitment. The protocol should be reviewed to consider several dimensions. Continue reading by downloading the free eBook at the link below!

Download the Strategies to Improve Clinical Trials DEI eBook

Contact us to learn more about how we can help improve DE+I in your clinical trials operations. You can also learn more about our other DE+I services here 

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Contributions from Jake Park-Walters

Tags: Clinical Operations, Diversity + Inclusion, Clinical Trials