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Reaching Diverse Patient Populations to Drive Inclusivity in Trials

Reaching Diverse Patient Populations to Drive Inclusivity in Trials

The COVID-19 pandemic was catalytic in highlighting gaps in health outcomes across the globe, with global health inequity disproportionately impacting minorities and communities of color.

With a litany of factors influencing individual patient outcomes and access to healthcare, there is a clear disparity in how many of these groups are represented in clinical studies; the FDA recently concluded that 80% of clinical trial participants are white. Furthermore, less than 20% of approved drugs are backed by data reflecting treatment efficacy for Black patients.

In short, there is a considerable diversity gap in clinical research, compounded further by three key barriers: patient trust, patient awareness, and patient access. Eradicating these barriers is imperative to facilitating trial diversity and, ultimately, health equity. In order to pursue effective diversity strategies in clinical trial recruitment, it is critical to understand these barriers and develop a plan of action to remove them.

  • Patient Trust: Connecting with patients starts with fostering trust. With a marred and persistent history of medical mistreatment against minorities, such as medical experimentation, disproportionate accounts of malpractice, and discrimination, these communities are understandably more hesitant and distrustful of the medical establishment.

    The first step is to acknowledge these historical failings and begin ameliorating cultural competence and awareness among clinicians. Organizations should consider developing tailored training programs to engage and educate providers on historical/structural contexts for health inequity and mistrust. These should also illustrate the social determinants of health and cultural dimensions that can impact how a patient perceives the medical system and their understanding of clinical trial participation.

    For example, many are hesitant about side effects and their safety when participating in a trial. In these cases, messaging used in recruitment strategies should directly address these concerns and provide adequate information to alleviate apprehension.

    Additionally, it might be fruitful to consult trusted community representatives and advocacy groups to understand these concerns on a fundamental level. Engaging with trusted leaders and influencers returns a voice to the disenfranchised, and can spur effective dialogue within the community, fostering trust and opening up more channels for prospective participants to willingly obtain trial-related information. 
  • Patient Awareness: Many clinical studies struggle to meet enrollment targets due to lack of patient awareness regarding ongoing trials and how they can get involved. This is often due to generally low or no health literacy, with limited understanding of the drug development process. In the US alone, 9 out of 10 adults have difficulties with health literacy, making it difficult for them to understand medical concepts, particularly when they are not adapted for layperson consumption.

    Furthermore, Limited English Proficient (LEP) patient groups are often excluded from recruitment efforts due to language barriers and a lack of accessible resources. This is often because clinicians are apprehensive about investing in the extra resources required, or there are concerns surrounding potentially ambiguous informed consent due to miscommunications or mistranslations. However, failing to translate and culturally adapt recruitment messaging during outreach to multilingual communities only serves to further exacerbate under-representation of LEP patients in clinical research. Long term, this perpetuates ongoing health inequities and poor health outcomes that are especially pervasive in LEP populations.

    Enhancing the quality and linguistic reach of your recruitment messaging is key to garnering multilingual patient awareness of your study. In fact, a 2013 study indicated that allocating Spanish phone interpretation resources in the recruitment phase increased engagement from Hispanic people by 10%. 
  • Patient Access: Often, culturally and linguistically diverse participants struggle with pursuing involvement in trials due to a limited number of ongoing trials on the national and regional level.

    This encompasses multiple dimensions, such as being unable to take time off work, not living within a reasonable distance to the trial site, or cost restraints associated with traveling to the site. These socioeconomic factors disproportionately impact minority populations, and should be considered in access improvement strategies.

    There are numerous approaches that can be taken to better understand and overcome access barriers for study participants, such as conducting feasibility questionnaires for study sites that evaluate patient demographics and ensuring linguistic diversity among available staff.

    At the clinical level, research organizations should work closely with medical facilities to integrate clinical trial recruitment into patient treatment pathways. Medical providers with a full understanding of their patients’ medical and socioeconomic backgrounds can be the missing link when connecting patients with clinical trial recruitment.  

Ultimately, the onus is on pharmaceutical companies to develop robust patient recruitment strategies that are adapted for diverse populations. In the fallout of the COVID-19 pandemic, there is ample opportunity to begin improving patient perception of clinical trials and evaluating the efficacy of outreach strategies. Considering the three key barriers to trial participation is essential to optimizing your clinical recruitment efforts.

Looking to develop patient-centric strategies and diversify your clinical research participation? TransPerfect has helped major pharmaceutical organizations and CROs develop successful bilingual paid media campaigns driving almost 12 million impressions across multiple channels. 
Contact to us today to learn more about our patient services and how we can support your organization.