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Clinical Trials Day 2022 – Planning for Diversity

Learn the practical applications of the FDA’s new guidance on Diversity Plans in clinical trials.
Learn the practical applications of the FDA's new guidance on Diversity Plans in clinical trials.

Today is Clinical Trials Day and UBC is grateful to be able to play a role in proving the safety and efficacy of therapies in clinical trials. We are also grateful for all the fantastic partners and HCPs we work with, and particularly thankful for the contributions that clinical trial participants make to advancing these therapies.

Today is also a strong reminder that it is essential for all stakeholders involved in clinical trial engagement to reflect on our responsibility to ensure clinical research reflects the diversity of all the patients the therapy will benefit. This helps to ensure equity and accuracy, as better representation of clinical trial participants allows us to learn more about the actual safety and efficacy of a potential therapy. Participants in clinical trials should reflect the diversity of the population, with particular attention to those most affected by the disease. Diverse representation includes everything from race, ethnicity, and age, to gender, socioeconomic status, and disease stage. By designing studies that are sensitive to the cultural and social norms of diverse populations, traditionally underrepresented groups can be better engaged in clinical research and better served by the therapies that become approved.

The FDA recently (in April 2022) issued guidance on improving diversity in clinical research, titled Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials.” The FDA has advised trial sponsors to submit a “Race and Ethnicity Diversity Plan,” which sets out diverse participant enrollment and retention processes early in clinical development – a key step to making diversity in each clinical trial a reality.

Here are some important considerations when designing your “Plan” in alignment with the recent Guidance:

Understand the Main Barriers

The main barriers to clinical trial participation from underrepresented groups have included:

  • Mistrust
  • Lack of information or lack of clinical trial awareness
  • Comfort with the research process
  • Access to resources or limitations in traveling to a study site
  • Logistical challenges and even technological challenges

It is critically important to include patients, caregivers, care partners, and community leaders in your conversation on how you address these barriers. Prior to your study launching, you should gauge interest, understand the barriers to participation, and see what changes would make the trial more accessible or even improve the trial design.

Cultural competency amongst site staff and sponsor teams designing trials is an ongoing issue that can be addressed from the beginning. Have the study team participate in cultural competency training and teach them how to address questions and concerns that come up about existing health inequities and previous research issues. It is essential to recognize the problems that occurred in research to forge a path towards improved inclusion and trust amongst participants.

Ways to Improve Diversity as part of your “Plan”

  • Developing meaningful patient advocacy relationships is critical to improving clinical trial education and awareness. Connect with community groups, places of worship, schools, and community associations around your sites or target communities. Establish partnerships with groups that have already engaged in creating these relationships.
  • Enlist advocates to educate, create awareness, and provide feedback on your strategy and plan. This will include patient advocates representing the disease and the diversity of different demographic groups.
  • Create study materials and use communication channels that are tailored toward the different communities that they will serve.
  • Ensure your clinical trial sites represent diverse areas and allow for the recruitment of diverse patients.
  • Work towards a diverse physician and site staff population. Some patients prefer being treated by a physician of their race, ethnicity, or gender. Identify thought-leaders on social media, or engage with groups like the National Medical Association, American Medical Women’s Association, or the National Hispanic Medical Association to meet these goals.
  • Make sure all patients have the resources to be able to access and participate in the trial. More and more trials are incorporating decentralized elements to various parts of their protocol. This creates new areas and methods of ensuring diversity that will need to be met.
  • Create trackable metrics on your recruitment to understand if diversity goals are being met in real-time. Leverage real-world evidence partners to help you identify unmet needs and gaps, and build dashboards.

We must do better in ensuring an accurate representation of all populations, not just those that have the easiest access to a clinical trial. Clinical trials bring hope to so many, and on this Clinical Trials Day, we need to all ensure that we are working toward the goal of developing better therapeutics for all people. As clinical trials continue to transform, there are new opportunities to reach diverse populations that we may not have reached in the past. A collaborative, multisector approach, strategic partnerships, and engaging with patients, caregivers, care partners, and providers by sharing best practices are opportunities to continue to advance underrepresented racial and ethnic minorities in clinical trials and create proactive plans to address diversity across clinical trials.

To learn more about UBC’s Patient and Physician Services contact us.

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Bekki Bracken Brown

President & Chief Executive Officer

Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.

With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.