The benefits of diversity and inclusion in clinical research are widely recognized, yet the financial and operational costs of these efforts are often overlooked. Practical strategies are needed to identify and mitigate these hidden costs, helping organizations create effective and sustainable strategies. These will be more important than ever if current U.S. Food and Drug Administration draft guidance on diversity action plans eventually goes into effect.
“One hidden cost is recruitment, with additional outreach, time, and resources required to reach underrepresented populations,” notes MaryAnn Bowman, Founder/CEO at ClinGRO Solutions. “Community engagement is a particularly costly but necessary activity to build trust. Costs can be minimized by steps such as forming community partnerships, using virtual engagement to host online meetings, training community leaders to enhance outreach, running partner programs with health initiatives, and using digital marketing to target specific populations.”
“Another hidden cost is training and education for research teams,” says Mitchell Hilbe, CEO/Co-Founder at DiversiTrials. “These typically include cultural competence training for site staff, as well as language-related resources. Retention of diverse populations can also demand additional investment in patient support, helping overcome logistical barriers to study participation such as travel and other costs.” Potential solutions may involve stipends for participants and caregivers, use of decentralized study elements such as telemedicine and home visits, funding for rideshares, and alternative incentives such as healthcare or wellness packages.
Efforts to improve diversity and inclusion can increase study timelines by slowing enrollment, while also increasing overheads and delaying market authorization for investigational products. “Mitigating approaches include the use of adaptive designs, where protocols are adjusted based on interim data to help prevent delays, as well as the use of recruitment specialists with expertise in diverse populations,” explains Bowman. “It’s vital that conversations continue about advancing diversity and inclusion, with improved collaboration between stakeholders to achieve diversity goals.”
The Hidden Costs of Diversity and Inclusion in Clinical Research
Join MaryAnn and Mitchell at ACRP 2025 [April 24-27; New Orleans, La.] as they explore the often-overlooked financial and operational costs associated with implementing diversity and inclusion practices in clinical research. View complete schedule.
By accurately calculating the costs of diversity and inclusion, these can then be fully accounted for in the study budget, reducing the burden on sites. “This in turn will lead to better studies and improved outcomes,” concludes Hilbe. “We need to reach sites located near underserved populations, offering education about how costs can be reimbursed, and providing tools and knowledge so that these sites can continue to serve their communities while advancing clinical research.”
Edited by Jill Dawson
