Abbott Unveils New Recommendations and Partnerships to Improve Diversity in Clinical Trials

• Abbott published 'Advancing Diversity in Clinical Trials' to share strategies to support diversified clinical trials in healthcare
• The company continues to build new partnerships designed to improve diverse enrollment in clinical trials, drive education about the research process, and empower diverse patients to improve their care
• Now in its third year, Abbott's Diversity in Clinical Trials initiative continues to ensure broad, diverse groups of patients are represented in the clinical trials process

ABBOTT PARK, Ill. - Nov. 19, 2024 - Abbott today announced that, in the third year of its multi-million-dollar Diversity in Clinical Trials initiative, the company has published 'Advancing Diversity in Clinical Trials' to share strategies to make clinical research and the teams leading these trials more diverse across the U.S. Concurrently, Abbott also revealed new partnerships to continue driving diversity in clinical trials by breaking down traditional barriers to care.

Simultaneously published in TIME Magazine, 'Advancing Diversity in Clinical Trials' draws on experiences and insights from a diverse group of nearly 100 experts in the field, including academic researchers, physicians, advocacy groups, clinical trialists, and experts within Abbott. The paper identifies and provides understanding about four key barriers to accessing clinical trials: lack of trust, lack of transparency, lack of access, and lack of a common language. To overcome these challenges, the paper highlights a number of key recommendations, including:

• Researchers should consider implementing inclusive hiring and study design practices to ensure patients see themselves reflected in the care team and staff running the clinical trial.
• Industry sponsors should deploy educational campaigns that clearly explain basic trial information and medical terms to increase understanding of clinical trials, the disease state and the need for a new treatment.
• Study design should allow for at-home devices to help patients log data remotely when possible to minimize the need for travel to in-person follow up visits.
• Researchers should ensure multi-lingual materials and translation services are available to all prospective patients.

"Clinical trials are the cornerstone of medical progress and they must reflect the diversity of the population they aim to serve," said Danielle Bajakian, M.D., Columbia University Irving Medical Center. "Abbott's insightful publication provides recommended strategies based on years of research and analysis that will help ensure adequate representation in clinical trials across diverse demographics. Ultimately, I need to be able to look my patients in the eye and say this treatment has been studied on patients like them, and this is why we should be using this therapy."

Driving Collaboration Across All Corners of the Medical Industry

Abbott has also expanded its Diversity in Clinical Trials program by fostering new partnerships aimed at engaging all corners of the medical industry to proactively address issues that may impact participation in clinical trials.

As part of Abbott's approach to strengthening communication around clinical research, the company recently launched www.abbottclinicaltrials.com to provide physicians and consumers with education and resources on clinical trials. Abbott also engaged the Center for Information and Study on Clinical Research Participation (CISCRP) to develop materials for this website to support awareness of clinical trials, enhance experiences, and strengthen communication and relationships among participants, research professionals, and the public.

In addition, Abbott has instituted a new pilot program to ensure participants' feedback in the design of clinical trials is incorporated in the design phase. In partnership with the National Blood Clot Alliance, Abbott will launch a first-of-its-kind diverse Patient Advisory Panel. The insights from this panel aim to optimize study logistics and improve enrollment, retention, and patient experience among a racially and ethnically representative population.

"Much of the medical information we have today is based on clinical research that doesn't include enough women and other underrepresented groups," said Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs for Abbott's vascular business, co-lead of Abbott's Diversity in Research Office, and one of the authors of 'Advancing Diversity in Clinical Trials.' "The recommendations in this new publication provide a roadmap to ensure a more inclusive healthcare system for everyone."

Leading By Example, Starting with Internal Best Practices

By 2025, the Food and Drug Administration (FDA) will require a diversity and inclusion plan to accompany all Investigational Device Exemption (IDE) submissions for new devices, which are necessary for clinical studies in the United States. Ahead of the FDA's requirement, Abbott has developed the required template and incorporated it into the company's submission process when applying for clinical trials.

Additionally, Abbott's Diversity in Research Office created an internal resource center to ensure all businesses across Abbott are equipped with tools and training to prioritize diversity and inclusion in clinical trial designs. Notably, Abbott developed a cross-divisional diversity data collection tool for patient-level data, including racial, ethnic, gender, socioeconomic, and LGBTQ+ information, to ensure clinical trial sites collect the information necessary to understand and create actionable solutions to the issues impacting different communities.

The result is a database across all of Abbott's businesses, measuring diversity in all of Abbott's clinical trials around the world. This approach allows Abbott to hold itself accountable to the high standards it sets, while also providing insight into progress so that changes can be made if needed.

Now in its third year, Abbott's Diversity in Clinical Trials initiative continues to increase access to care for underrepresented populations. In 2023, females made up 54% of Abbott's clinical trial participation in the United States, while Hispanic/non-white people made up 44%. These percentages closely align with United States census data, showing that Abbott's clinical trials are representative of the population. Furthermore, Abbott has awarded nearly 150 scholarships through partnerships with Historically Black Colleges and Universities (HBCUs) and nursing associations to increase the number of physicians, nurses and research coordinators from diverse backgrounds who can lead the future of clinical trials. By continuing this strategic initiative and creating and participating in programs that provide greater accessibility to underrepresented and underserved groups, Abbott is driving medical innovation.

To learn more about Abbott's Diversity in Research initiative and the Diversity in Research Office, visit http://www.abbottclinicaltrials.com/.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

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