Committing to Our Clinical Trial Communities

Clinical trials are a vital part of the process that brings innovative products and treatments to people in need. No matter the disease or condition, the overarching goal remains the same:

Provide the best care options to all people in need.

However, the unfortunate fact is that racial and ethnic groups have long been underrepresented in clinical trials.

In 2011, African Americans and Hispanics made up 12% and 16% of the U.S. population respectively, but only 5% and 4% of clinical trial participants.1 The divergence in these numbers affects not only the communities but the science.

It is well-known that some groups of patients may respond differently to medical therapies (women reacting differently than men; ethnic groups differently from each other). From 2008-2013, the U.S. Food and Drug Administration approved 167 new molecular entities (potential medications), around 20% of which had different effects across racial and/or ethnic groups.2

Recently, participants in a majority of COVID-19-related trials were predominantly white populations although it is widely known the disease disproportionately affects underrepresented groups.3 The findings are clear. Trials need to include a more diverse population that more accurately reflects its target audience.

Abbott's Commitment

We realize the importance of ensuring appropriate gender, racial and ethnic representation in clinical trials and are developing an outreach plan to build trust in areas where trial participants have not traditionally been included.

With the understanding that this is a long-term commitment, we want to work with others who recognize the need to overcome four substantial barriers to diverse participation in clinical trials:

• Lack of access to facilities/trials/resources in the area.
• Lack of understanding as to benefits to self or community through participation.
• Lack of trust in institutions or individuals due to prior bad experiences.
• Lack of a single common language.

Part of our program is the formation of a Diversity Advisory Board, with the goal of determining how best to increase participation across gender and ethnic lines. Some of the ways we plan to overcome these barriers and progress in this area include:

• Recruiting talented women/ethnically diverse doctors who reflect their communities and are interested in clinical trials by providing training, development and coaching.
• Working with medical centers in diverse communities that do not have extensive experience in medical research, while connecting with diverse participants and cultivating trust and education through use of culturally-appropriate materials.
• Developing multi-ethnic and multi-gender patient facing materials and assets in multiple languages.
• Measuring our progress.

These efforts are also an important part of Abbott's broader work to advance health equity. As part of our 2030 Sustainability Plan, we're working across our business and in partnership with others to address health disparities, expand access and remove barriers that prevent people from living healthy lives, wherever they are.

Step One: The LIFE-BTK Clinical Trial

Every long journey starts with a single step. Ours is the LIFE-BTK trial.

A little background:

Twenty million Americans suffer from Peripheral Artery Disease (PAD), an extremely costly and dangerous medical condition that has a 33% mortality rate over five years, more than three times that of breast cancer. PAD can cause reduced blood flow, which can lead to amputation and death.

Abbott is conducting a clinical trial on the Espirit BTK System which will evaluate the Everolimus Eluting Resorbable Scaffold. This will involve a very small scaffold placed within the diseased artery designed to hold it open, provide medication and eventually have the scaffold absorbed by the body.

Why are we mentioning this clinical trial? Fact is that African-Americans are twice as likely to have PAD as any other racial/ethnic group and four times as likely to require an amputation. This clear correlation between specific disease process and demographic group is the reason we are using this as a model to improve clinical trial participation in under-served populations.

We have made a commitment to lead by example in recruiting for the LIFE-BTK trial, focused on people of color, Latinx, native populations and women and our investigators are representative of the people they serve. They include:

• Joel Rainwater, M.D., who serves a Native population.
• Lyssa Ochoa, M.D., who serves a Latinx population.
• Danielle Bajakian, M.D., who serves a multi-ethnic population.
• Sahil Parikh, M.D., who serves a multi-ethnic population.

Step 2: Collaboration and Patient Focus

While the LIFE-BTK trial is an exciting step for us to take, it is only one of many. All our businesses are committed to expanding clinical trial access to underserved communities. We need to do our best to ensure that our clinical trial community represents the variety of patients we hope to serve.

Just like we recognize that one size does not fit all when it comes to our trial participants, the same is true of those who conduct the studies. We all benefit from a variety of perspectives. Which is why we are also working with physicians and within the broader industry to make meaningful change.

Part of that transformation is through our role on the Advanced Medical Technology Association (ADVAMED) advisory board on racial disparities in healthcare. This team is dedicated to reaching equity in patient care by improving access to medical device technology for all people and communities.

By including talented investigators who are invested in their communities and providing necessary resources both within the company and the device industry, we are further building the foundation for equitable and relevant studies long into the future.

Because we aren’t interested in short-term fixes. We want to be part of a lifelong commitment to better health for everyone.

References:

¹ The Society for Women's Health Research United States Food and Drug Administration Office of Women's Health. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials; 2011

² A. Ramamoorthy, M.A. Pacanowski, J. Bull, et al. Racial/ethnic differences in drug disposition and response: review of recently approved drugs. Clin Pharmacol Ther; 97 (2015): 263-273

³ Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020; FDA Briefing Document