OBJECTIVES: To understand current initiatives undertaken by pharmaceutical and life science companies to improve clinical trial diversity in the US and recommend tactics to help companies improve their inclusion of underrepresented racial and ethnic groups within their trials.

METHODS: 60-minute qualitative research interviews with 15 pharma/life sciences company executives involved in executing and spearheading diversity initiatives for clinical trials in the US for their organization.

RESULTS: Efforts to enhance diversity and inclusion in US clinical trials are pervasive and expanding. Life science and pharmaceutical companies acknowledge the importance of underrepresented populations for robust and generalizable research outcomes in their trials, however recruiting these patients is often challenging. Our research found that companies have enacted a wide array of strategies including creating dedicated teams to address challenges in recruiting diverse populations, broadening eligibility criteria, expanding trial locations, and on-the-ground initiatives targeting specific demographic groups. These initiatives have yielded inconsistent success and efforts are often still limited by human and financial resources.

CONCLUSIONS: Despite progress, challenges persist in recruitment and retention. With the FDA’s draft guidance getting closer to becoming final, companies are focused more on the clinical trial diversity strategies more now than ever before. This research provides directives on initiatives life sciences companies can consider to support their diversity enrollment goals.