Closing the Diversity Gap in Clinical Trials: The Importance of Achieving Inclusion

The COVID-19 pandemic has highlighted disparities in health outcomes around the world, with global health inequalities disproportionately affecting minorities and people of color.

Many factors influence individual patient outcomes and access to care, and there are stark differences in the representation of these groups in clinical studies; the latest data shows that about 80% of clinical trial participants are white. In addition, data for less than 20% of approved drugs reflect treatment effects in black patients.

In short, a significant diversity gap exists in clinical research, driven by three key barriers: patient trust, patient awareness, and patient access. Removing these barriers is critical to promoting diversity in trials and achieving health equity. To effectively implement diversity strategies in clinical trial recruitment, it is critical to understand these barriers and develop an action plan to eliminate them.

Patient Trust: Building Connections with Patients

The first step to building patient trust is to prioritize the cultivation of trust. Due to historical medical abuses against minorities, such as medical experimentation, disproportionate medical errors, and discrimination, these communities naturally hold more hesitation and distrust of the medical establishment.

First, we must acknowledge these historical failures and begin improving clinicians’ cultural competence and awareness. Organizations should consider developing customized training programs to help providers understand the historical/structural context of health inequities and mistrust. These trainings should also illuminate the social determinants and cultural dimensions that influence how patients view the healthcare system and their understanding of clinical trial participation.

For example, many people are hesitant to participate in a trial regarding side effects and safety. In this case, the messaging used in the recruitment strategy should directly address these concerns and provide enough information to ease uneasiness.

Additionally, it may be beneficial to consult with trusted community representatives and advocacy groups to gain a deeper understanding of these fundamental issues. Engaging with trusted leaders and influencers can give voice to the disenfranchised and foster effective dialogue within the community, thereby building trust and opening more channels for potential participants to voluntarily access trial-related information.

Patient Awareness: Raising awareness of participation

Many clinical studies struggle to meet enrollment targets due to a lack of patient knowledge of the trials being conducted. This often stems from low or no overall health literacy, leading to limited understanding of the drug development process. In the United States, only 10% of adults face difficulties with health literacy, making it difficult for them to understand medical concepts, especially when those concepts are not adapted for the average person.

Additionally, LEP patient populations are often excluded from recruitment efforts due to language barriers and lack of accessible resources. This is often because clinicians are wary of committing additional resources or are concerned that informed consent may be ambiguous due to miscommunication or mistranslation. However, when outreaching to multilingual communities, failure to translate and culturally adapt recruitment information only further exacerbates the lack of representation of this group of patients in clinical research. In the long term, this will perpetuate ongoing health inequities and poor health outcomes that are prevalent among LEP populations.

Improving the quality and language coverage of your recruitment information is critical to increasing awareness of your study among multilingual patients. In fact, a 2023 study showed that assigning Spanish phone interpreting resources during the recruitment phase increased participation from the Hispanic population by 10%.

Patient Access: Improving Opportunities for Engagement

Culturally and linguistically diverse participants are often difficult to include due to the limited number of trials conducted at the national and regional level.

This involves multiple aspects such as inability to take time off work, long distances from trial sites, or financial constraints in travelling to the sites. These socioeconomic factors disproportionately affect minority populations and need to be considered in strategies to improve access.

Several approaches could be taken to better understand and overcome barriers to access for research participants, such as conducting feasibility questionnaires for research sites to assess patient demographics and ensuring language diversity among available staff.

At the clinical level, research institutions should work closely with medical facilities to integrate clinical trial recruitment into the patient care process. Medical providers who fully understand the medical and socioeconomic background of their patients can be the key link between patients and clinical trial recruitment.

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