Making the Cutting Edge More Equitable: 5 Strategies to Drive Diversity in Clinical Trials

Making The Cutting Edge More Equitable 5 Strategies To Drive Diversity In Clinical Trials Web

The COVID‑19 pandemic highlighted long‑standing and vast inequities in the US healthcare system. As one critical step to combating this injustice, organizations must strive for equitable representation in their clinical trials.

For the first time in US history, clinical trial coordinators must adhere to a statutory requirement for increased diversity in their trials’ patient panels. Signed by President Biden in December 2022, the Consolidated Appropriations Act, 2023 (Public Law 117-328) requires diversity action plans for clinical trials, providing a long-needed framework to generate clinical trial participation that is representative of the population.

The law directs organizations to increase access to and the diversity of their clinical trials. To drive better representation in clinical trials, it is important to understand the relationship between underrepresented populations and the history of clinical trials in the US, along with the current barriers that exist across the clinical trials enrollment process. From there, organizations can develop sustainable strategies to ensure their clinical trials are truly representative of the populations they serve.

Establishing Trust and Overcoming the Past

Clinical trials provide access to novel medical treatments and innovative care for patients seeking specialized medical services for conditions ranging from chronic illnesses, like diabetes, to the most rare and complex cancers. Late-stage clinical trials are more likely to show success and some are even considered standard of care in specialty areas like oncology. As such, providing access to and establishing trust in the clinical trials process is essential to ensure the best outcomes possible for all patients.

In part due to a painful history with clinical research and the medical community as a whole, as well as structural economic, geographic, and communication-based barriers, people of color are underrepresented in clinical trials, a significant contributing factor to racial healthcare inequity. As provider and research organizations look to progress their diversity, equity, and inclusion (DEI) efforts, a critical element will be the development of robust mechanisms and inclusive processes to ensure medical research is representative of the populations they serve.

Importance of Designing Representative Trials

Organizations need to understand the clinical trial panel selection process and the structural barriers it poses to accurate and equitable representation (see figure 1). First, a potential trial candidate must be in a region offering the appropriate trial; most clinical trial recruitment and study visits take place at academic institutions that may be difficult to access for many underserved communities due to transportation barriers. Additionally, the patient must have the economic means to participate in the trial, including the ability to pay for any travel, take time off work, etc.

Patients who overcome these initial barriers must also be made aware that they are eligible for a particular trial. While proactive and medically savvy patients may be able to identify a potential clinical trial and advocate on their own behalf to participate in one, most patients are unfamiliar with the intricacies of the process and therefore rely on their care team to broach the topic.

Figure 1: Barriers to Accurate and Equitable Clinical Trial Representation

But overcoming geographic and economic barriers is only the tip of the iceberg. Communication challenges and deep-rooted mistrust further inhibit enrollment.

  • Language barriers often make it difficult to communicate the benefits of clinical trials to non- English-speaking populations.
  • People of color may view clinical trials through a lens of fear, mistrust, and skepticism due to their historical mistreatment and exploitation by the healthcare community in the name of medical research and scientific experimentation.
  • Diversity in national academic medical school faculty and leadership is lacking, with little improvement observed over the past several decades.2 Individuals are more likely to trust medical advice from someone with whom they identify. As such, inadequate representation hinders the ability for a trusting provider-patient relationship and, in turn, a patient’s willingness to participate in a clinical trial.

While adequate representation of underrepresented populations in clinical trials is essential to providing individual participants with access to cutting-edge medical treatment, it is equally critical to ensuring future patients receive tailored, high-quality medical care. There are countless examples of studies where the results appear clinically significant and beneficial but the participant panel insufficiently represents the broader population, leading to potentially discriminatory care protocols. It is essential to develop robustly representative trials to ensure standards of care are equitable and provide underrepresented populations the same improved clinical outcomes as their peers.

Awareness of healthcare inequity across America is growing, and making the clinical trials process more inclusive is one tangible step that healthcare organizations can take to redesign a system that is equitable for all.

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Edited by: Emily Johnson
Designed by: Mary Anne Akhouzine