This panel of real-world evidence (RWE) experts explore the economic impact and role of RWE in improving representativeness of research.

Despite the FDA guidance put forth in 2020 to enhance diversity in clinical trials, many populations remain underrepresented; particularly, racial and ethnic minority groups, women, and elderly individuals. This underrepresentation of disproportionately burdened groups limits information on therapeutic response, safety, and efficacy to a small subset of the population that tends to be healthier, more well-educated, and financially advantaged. Less than 20% of FDA drug approvals in the past 5 years had reported adverse effects or treatment benefits on Black participants1.

Approvals based on limited data can have detrimental economic as well as clinical consequences. In a 2022 report from the National Academies of Science Engineering and Medicine, it is estimated that hundreds of billions of dollars will be lost in the U.S. over the next 25 years due to the impacts of underrepresentation in clinical trials, specifically in chronic diseases such as diabetes, heart disease, and hypertension2.

Key Topics Include:

  • Review the current state of clinical trial underrepresentation
  • Understand how real-world data and RWE can help fill gaps in representativeness of clinical trials
  • Explore the economic impact of underrepresentation in clinical trials

1) https://www.healthaffairs.org/doi/10.1377/hlthaff.2021.01432

2) https://healthpolicy.usc.edu/article/lack-of-diversity-in-clinical-trials-costs-billions-of-dollars-incentives-can-spur-innovation/

Resources

Presenters

Chief Medical Officer
Specialty Solutions
Cardinal Health

Bruce Feinberg, D.O., is Vice President, Clinical Affairs and Chief Medical Officer for Cardinal Health Specialty Solutions. He is nationally recognized for his expertise in specialty oncology and the business of specialty healthcare.

Senior Scientist
Real-World Evidence and Insights
Cardinal Health

Danielle Gentile, PhD is a Scientist for Real-World Evidence and Insights at Cardinal Health. She investigates the health outcomes of patients treated in real-world settings outside of clinical trials. She earned her PhD in Health Promotion, Education, and Behavior from the Arnold School of Public Health at the University of South Carolina.

Lead Statistician
Real-World Evidence and Insights
Cardinal Health

Parisa Asgarisabet, PhD is the Lead statistician for Real-World Evidence and Insights team at Cardinal Health. Her expertise lies in statistical analysis, database management, and clinical and economic outcomes research of real-world data from chart review forms, administrative claim databases, disease registries, and patient-reported data.

Lead Publication Scientist, Strategic Research
Real-World Evidence and Insights
Cardinal Health

Alexandrina Balanean is the Lead Publications Scientist, Strategic Research, at Cardinal Health, working in the greater Chicago area. She has over 15 years of experience in scientific research and communication, including medical writing, editing, and managing peer-reviewed journals.

Production Partner

Cardinal Health

Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 30 countries and approximately 44,000 employees globally, Cardinal Health is essential to care.

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