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Participation

Making Clinical Research More Inclusive

As we do each February in the U.S., we’ve been learning about the contributions of both ordinary and extraordinary people during Black History Month. Often, it is ordinary people doing extraordinary things that can make the greatest impact on the world.

At Lilly Trials, we are focused on making an impact on health through clinical research, and we talk a lot about both the promise and the problems of research. The promise is that clinical research will bring new and better treatments for the world’s diseases. One of the problems is a lack of diversity among clinical trial participants.

Why Diversity Matters

The racial and ethnic makeup of clinical trial participants is often not reflective of people who will ultimately use the medicine. Did you know that African Americans represent 12% of the U.S. population but only 5% of clinical trial participants, and Hispanics make up 16% of the population but only 1% of clinical trial participants?

The impact of disease isn’t the same for everyone, either. Various health disparities exist between different ethnic and racial groups. In the U.S., people of color experience a higher incidence of some conditions, such as stroke and diabetes, than whites. For example, we know that African Americans and Hispanics are about twice as likely to be diagnosed with diabetes as non-Hispanic whites. What’s more, research shows that responses to medications can vary depending on a number of factors including genetic background and ethnicity. With a balanced representation of various races in clinical trials, researchers can better understand how factors like efficacy and dosage affect people differently and can improve treatments for all.

In order to better understand these variances and improve treatments for the people who need them, it’s critical that clinical trials include diverse populations. Minorities have historically and consistently been underrepresented in clinical trials, and barriers to participation still exist today. Here are some of the most prevalent obstacles:

Trust
  • People of color have historically been mistreated and may have distrust of the medical community, industry and government
  • Fear or feeling of being used as a guinea pig
Awareness
  • People are not aware of clinical trials in general and therefore may not be aware of how clinical trials advance medical care
Structural Obstacles
  • Transportation to clinical trial sites may be unreliable or unavailable
  • Arrangements for childcare may be difficult or expensive
  • People may be unable to take time off work to attend a clinical trial visit
Study Eligibility Criteria
  • Some participants may not be eligible for a particular clinical trial because of existing medical conditions or medications they are taking
Cost and Insurance
  • It’s not always clear whether an individual’s benefit plan will cover the cost of clinical research
Language Barriers
  • Some participants and caregivers prefer information in languages other than English
  • There is an ongoing need for health care interpreters in clinical research
Administrative Complexity
  • Consent forms are long, complex and technical
  • People may have concerns about—or fear a loss of—control or legal rights once they signed the informed consent
Understanding Benefits
  • Currently, potential benefits are not always explained clearly to participants
  • People may not realize that those participating in clinical trials often receive higher quality health care, time and attention

Three Partnerships to Increase Diversity in Clinical Research

Because these barriers exist industry-wide, Lilly is partnering with other pharmaceutical companies and academic institutions to address them through several initiatives.

1. TransCelerate BioPharma, Inc.

Lilly is a founding member of TransCelerate BioPharma, Inc., a non-profit organization aimed at improving health around the world by simplifying and enhancing the research and development of new therapies. One of the areas of focus for TransCelerate is clinical trial diversification, and they have recently provided their better practice recommendations for improving the engagement and recruitment of minority patient populations. We will be following many of these recommendations in our clinical research.

2. Center for Drug Development and Clinical Trials at Roswell Park

Roswell Park—founded in 1898 in Buffalo, New York—was the nation’s first cancer center and continues to advance cancer research today. Our partnership aims to increase the number of investigators of color in clinical research by training physicians of color to lead clinical trials through a series of ongoing workshops.

3. Tuskegee University Collaboration to Enhance African American Participation in Clinical Trials

Tuskegee University—founded in 1881 in Alabama—is a national, independent, and state-related institution of higher learning. This institution is an HBCU (Historically Black College or University) that today serves a racially, ethnically and religiously diverse student body. Tuskegee University and Lilly are partnering to increase diversity in clinical trials to ensure that African Americans benefit equitably from medical advancements. In an effort to heal the mistrust resulting from historical mistreatment of people of color in clinical research, the partnership will include applied research, education and community engagement.

These partnerships are examples of many people working together to do extraordinary things to increase diversity in clinical research so that we can improve health care for all. After all, everyone benefits from making clinical research more inclusive. We welcome your thoughts on this topic and invite you to comment below or to @LillyTrials on Twitter.

Blog post originally appeared on LillyPad.

Tags: Diversity,

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