Diversity In Clinical Trials: Recent Efforts From The MedTech Color Collaborative

By Kenita Barrow, Otsuka America Pharmaceutical, Inc.

In any product or service industry it is necessary to understand the population being served to meaningfully impact their daily lives. The health technology industry is full of bright minds working together to make lasting, positive impacts on the lives of people worldwide. To best serve this diverse group, it is necessary to ensure that the individuals reflect, and strategies supporting product development consider, the people they are intended to serve.

Entities such as academia, the FDA, and advocacy groups have taken steps to begin addressing the issue of diversifying the health technology industry. These organizations have pushed forward programs as well as convened focus and discussion groups aimed at advancing individuals of color in the life sciences — particularly in clinical research and product development. For creating a pathway for diversity in the medtech industry specifically, please see my recent article here.

One example of this includes guidance released in November 2020 from the FDA on enhancing diversity in clinical trials. The guidance touches on eligibility criteria, enrollment practices, and trial designs. It concludes that enhanced diversity in enrollment practices can lead to clinical trials that better reflect the population most likely to use a drug if it is approved.

Earlier this year, the MedTech Color Collaborative (MTC Collaborative) was created with a goal of convening a diverse cross-section of industry stakeholders to work together to identify issues and opportunities for improvement in this critical space. The group shares and curates existing knowledge and strives to develop evidence-based solutions and best practices for all relevant stakeholders to address the health inequities and inequalities facing minorities.

Increasing Inclusion, Awareness, And Access

The MTC Collaborative is seizing the opportunity to develop thoughtful, proactive, and evidence-based strategies to address and mitigate the impacts of unconscious bias, social determinants of health, and lack of inclusion or consideration of racial and ethnic minorities in critical aspects of the health technology industry.

These issues influence critical processes such as strategies around early product development, including characterization of disease pathways and disease progression and clinical trial determinations (e.g., location, platforms for clinical trial engagement, multilingual needs, and resources to address implicit bias), as well as overall product safety and effectiveness in racial and ethnic minority populations.

As a result, the MTC Collaborative community is working to develop targeted strategies, including education, guidelines, best practices, and thought leadership to increase the awareness, understanding, access, engagement, and participation of underrepresented groups on the following issues:

• Disease state awareness, prevalence, and symptomology presentation in minority populations
• Recruitment and retention of minority patients, investigators, and other stakeholders
• Product development and clinical research
• Evidence development, analysis, and identification of unmet needs and minority health issues

Recently, the Collaborative moderated a discussion to inform patients and healthcare providers about the process, benefits, and considerations of participating in clinical research from the perspective of diverse patients, researchers, and other experts. This was the first of many events that will focus on information sharing and the development of micro-learnings to build awareness and break down barriers that may be limiting access or causing hesitancy for minorities around participation in clinical trials.

A Focus On Clinical Trials

Clinical trials not only help evaluate medical products and therapies for safety and efficacy, but they also provide insight into what works best for people with certain illnesses or for certain sub-populations.¹

There is a consistent underrepresentation of diverse patient populations in clinical trials. This is of particular concern when viewed through the lens of the prevalence of the relevant disease states found in the diverse patient populations covered by these trials. African Americans make up 13.4 percent of the U.S. population but only 5 percent of clinical trial participants. Furthermore, Hispanic/Latinos represent 18.1 percent of the U.S. population but less than 1 percent of trial participants.²

Inadequate participation and consideration of racial and ethnic minorities in product development, including clinical research, reduces the generalizability of research findings. It also creates disparities in the safety, quality, and effectiveness of treatments and therapies. Lastly, it decreases opportunities to deliver high-quality care and targeted therapies to underserved minority populations.

There also exists an inherent mistrust in the medical system, which impacts the willingness of underrepresented groups to seek out medical care or participate in clinical trials. Fostering relationships with physician groups and patient advocacy organizations is a critical step in building such trust. Equally important is creating and supporting community education and hearing trusted voices’ views on health and wellness.

In addition, there is a need to increase investigators from diverse populations so that they are reflective of the patient populations that most need to be reached. Participants may feel more comfortable when they can relate to the individuals conducting and staffing a clinical trial. Other considerations for facilitating diverse recruitment in clinical trials include geographic location and ensuring adequate ongoing access to trial sites. Making the trial virtual when possible may also be a means to create a more diverse clinical trial subject population.

Otsuka has been able to facilitate reaching underserved and underrepresented communities utilizing the latest digital technology to create a fully remote clinical trial experience in its Mirai study evaluating the effectiveness of digital therapeutics.

Several tools can be used to move these considerations forward. These include social media, real-world data, and community outreach.

• Social media is often touted for its ability to reach across racial, socioeconomic, and varying age groups. Because of this, it has the potential to be a powerful tool that can be used to reach a broad array of trial participants. In addition to wide accessibility, social media platforms are generally easily viewable and provide the opportunity for users to readily share information through their social networks. As such, social media platforms (e.g., Facebook, Twitter, and Instagram) are replacing many of the traditional methods used by industry to advertise to potential clinical trial participants.
• Real-world data, such as electronic health and medical records when used with appropriate privacy and security measures, can help source best locations for clinical trials. This data, in a non-identifiable aggregated format, provides useful information on incidence and prevalence of disease states in a given region, informing which local institutions may be best suited to house a clinical trial site and encouraging engagement with community medical practices and HCPs in these geographies. Ultimately, this results in opportunities for increased access and ensures that underrepresented populations are appropriately represented in accordance with the prevalence of the respective disease state for a clinical trial.  
• Lastly, community outreach efforts made by building and fostering ongoing relationships with community organizations and leaders can assist in not just furthering information about the availability of clinical trials but also in working to bridge the historical gaps in trust surrounding clinical trials commonly found in minority communities.

Looking Ahead

The opportunities on the horizon resulting from the speed of innovation and increased convergence of novel technologies, such as artificial intelligence and machine learning paired with traditional diagnostics and drug treatments, further underscore the need for inclusiveness in the product development pathway.

Simply put, moving the needle forward in addressing health inequities must include diversifying clinical trial patient populations. The MedTech Color Collaborative, through its committed members, has the potential to be a force for change in this space, increasing diversity in the product pipeline and advancing tailored treatments and positive therapeutic outcomes for racial and ethnic minority communities.  

About The Author:

Kenita Barrow is executive director, deputy general counsel for Otsuka America Pharmaceutical, Inc. Outside of her legal role, she donates time to STEM programs for young women and to initiatives working to increase diversity in all areas of clinical research. She is a member of the Executive Planning Committee for the MedTech Color Collaborative and serves as a member and past chair of the Montgomery County Ethics Commission in Maryland. Barrow has a J.D. from Vanderbilt University, a B.S. in biology/sociology/philosophy from the University of Maryland Baltimore County, and has completed graduate work in the Pharmacology and Interdisciplinary Program in Neuroscience at Georgetown University.