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Improving Diversity In Clinical Trials With A Community-Based Approach

By Nick Davies, EY-Parthenon | June 9, 2022

How we address health disparities, especially regarding race and ethnicity, is critical to improving health outcomes for patients of all backgrounds. But the lack of diversity in clinical trials, due to shortcomings in the recruitment and retention of underrepresented patients, has been an issue. Clinical trial diversity is key to ensuring that approved medications are safe and effective for the intended treatment populations.

Executives of clinical trial sponsors and clinical research organizations (CROs) must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, executives can increase the understanding of novel therapies and further enable improved healthcare outcomes for all.

FDA Snapshot Of The Current Clinical Trial System

In the FDA’s Center for Drug Evaluation and Research’s (CDER) 2020 Drug Trials Snapshots Summary Report, 75% of participants in clinical trials for approved novel drugs were white, compared to other nationalities (11% Hispanic, 8% Black or African American, and 6% Asian). In response to this contrast, the FDA recently published updated guidance on enhancing the diversity of clinical trial populations and participation. Yet, there is no single solution to address the current lack of diversity among clinical trial participants, as shown by an EY-Parthenon survey of 176 patient respondents. Instead, executives should consider a series of connected, multifaceted solutions to address existing recruitment and retention shortcomings.

We believe that sponsors and CROs should explore a community-based approach to patient diversity in clinical trials. This would mean increasing patients’ general awareness and knowledge of the clinical trial process along with improving access to trials. Within both the biopharmaceutical (biopharma) and healthcare industries, as well as among lawmakers and regulators, there is more urgency around addressing the need for broader representation within clinical trials (this includes both the FDA guidance and bills in both the House and Senate).

Preclinical Trials

First, sponsors and stakeholders should actively listen to and directly engage with the patient populations that they seek to enroll in clinical trials. This is a critical step, especially given the longstanding mistrust among non-white communities related to medical research and healthcare, as well as a current misalignment between the specific needs of some patient communities and sponsor strategies. For example, our survey indicates that trial awareness programs and increased compensation are two of the top three ways to increase diversity in clinical trials, as noted by patients. Yet, there are minimal plans by companies to either initiate or continue either of these tactics. Engaging in two-way learning between industry and patients is key to increasing equity in clinical trials.


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