In the realm of health care, diversity is not just a goal but a necessity. Diversity in clinical studies (trials) is essential to ensure that medical research accurately reflects the population, addresses historical inequities in health care research, improves scientific rigor of the research, builds trust between minority communities and the health care system, and ensures that all groups can benefit from effective therapies and advances in medical research. In the field of urology, this need is particularly pressing due to the significant disparities in health outcomes among different racial and ethnic groups. For example, a review of urological oncology trials from 2015 to 2020 found significant underrepresentation of minority participants.¹ Clinical studies for prostate cancer had 4% Black, 3.6% Hispanic, and <1% American Indian/Alaska Native participants. Trials for urothelial carcinoma had 2.3% Black, 2.4% Hispanic, and <1% American Indian/Alaska Native. Moreover, enrollment of Black participants declined over time for prostate cancer studies, a tragic observation since this disease disproportionately impacts African American men.¹ This lack of diversity can lead to gaps in knowledge about how different populations respond to treatments, potentially exacerbating health disparities.

Efforts to Enhance Diversity

To address these challenges, several initiatives and guidelines have been introduced:

1. Food and Drug Administration (FDA) Guidance: The FDA has issued guidance to enhance diversity in clinical studies. This includes recommendations on designing and executing studies that include people with different demographic characteristics.^1,2
2. Diversity Action Plans: Clinical study sponsors will soon be mandated to submit diversity action plans. These plans outline strategies to enroll a study population that reflects the patients who will ultimately be treated.^2-4
3. Minority-Serving Institutions: Improve funding to minority-serving institutions as recruitment sites that have access to the study population.⁵ These institutions have a wealth of potential for community and clinical participatory research.
4. Community Engagement: Engaging with minority communities and physicians with access to minority patients through outreach and education can help increase participation in clinical studies. Building relationships with community leaders and organizations is key to this effort.

The underrepresentation of African American physicians and patients in urological studies has long been a concern, impacting the quality of care and health outcomes for minority communities and widening the disparity gap. To address these issues, the Consortium on Disparities of Urologic Conditions (ConDUC), in collaboration with the AUA, launched a groundbreaking mentorship training program (MTP), aiming to increase the enrollment of African American physicians and patients in clinical studies. This MTP seeks to dismantle obstacles to participating in urological clinical studies by providing support, guidance, training, and opportunities to urologists interested in clinical studies.

Program Overview

The MTP pairs mentees in the early stages of their careers with urologists experienced in clinical studies. The program offers:

1. Educational Information and Good Clinical Practice Certification: An on-demand web-based educational training module, knowRx, developed by the National Medical Association, comprehensively reviews all phases of clinical research—that is, evolution of drug regulation, physicians as clinical trial investigators, patient recruitment and retention, the informed consent process, managing adverse events, and surviving an FDA audit. Additional modules developed in collaboration with the National Cancer Institute, MD Anderson Cancer Center, American Cancer Society, and MDx provide supplemental information on regulatory compliance and ethics, institutional review board, and practical exercises and workshops.
2. Academic Support: Mentors provide career guidance and academic resources to help mentees excel in research.
3. Networking Opportunities: Access to a network of professionals and peers for career advice and job opportunities.

Success Stories

The program has already seen significant success. The inaugural program had 5 urologists and their clinical research team. Participants completed 2 surveys regarding the effectiveness of the program. Overwhelmingly (92% to 100%), the respondents strongly agreed/agreed that the program (1) met their educational needs using a combination of meetings, networking opportunities, and online educational modules, (2) allowed mentees to engage with peers in a supportive learning community, and (3) rated the program as excellent/very good. Each participant received a certificate for completion of the program as well as a good clinical practice certification.

Impact on Patient Care

Increasing the number of African American urologists is not only about representation, but also about improving patient care. This mentorship program aims to bridge the gap, ensuring that all patients have access to culturally competent care providers who are adequately and effectively trained to participate in clinical studies and understand their unique health challenges.

Looking Ahead

The MTP is a beacon of hope for many aspiring African American and other urologists interested in participating in clinical studies. By fostering a supportive and inclusive environment, it aims to create a ripple effect that will benefit the entire health care system. As more African American urologists complete their training, the hope is that they will complete the MTP and, in turn, mentor the next generation, creating a sustainable cycle of support and empowerment.

In conclusion, ConDUC’s MTP is a vital step toward achieving greater diversity in medicine and urology. By investing in the future of African American physicians and patients, we are not only enriching the medical profession, but also paving the way for a healthier, more equitable society. By ensuring that clinical studies include proportionate participants from all racial and ethnic backgrounds, we can develop treatments that are effective for everyone and build a more inclusive and trustworthy health care system.

Acknowledgments

The AUA and ConDUC thank AstraZeneca for their generous support of the 2024 Mentorship Training Program.