Briana Contreras, an editor with Managed Healthcare Executive, spoke with Harsha Rajasimha, MD, founder and executive chairman of IndoUSrare, in this month's episode of Tuning in to the C-Suite podcast.
The conversation was about how the disparity in diversity and ethnicity in rare disease clinical trials in the U.S. has led to gaps in understanding diseases and conditions, jeopardizing universal health, and increasing the economic burden of healthcare.
Time stamps of conversation
- 1:35 - Current disparities in diversity and ethnicity that are in rare disease clinical trials in the U.S. today.
- 4:05 - How these disparities impact our understanding of rare diseases and conditions.
- 7:05 - How the representation of these diverse populations in clinical trials can contribute to an increased economic burden on the healthcare system.
- 9:04 - Examples of rare diseases that lack of diversity in clinical trials more than others.
- 11:53 - Initiatives being implemented to address the diversity gap among rare diseases overall in clinical trials.
- 15:34 - How increasing diversity and representation in clinical trials benefits both patients and the healthcare system as a whole.
- 18:24 - The role IndoUSrare plays into fostering change into the representation of minority groups in clinical trials.
Dr. Rajasimha also shared some examples of rare diseases that have been affected most by the lack of diversity in clinical trials, but even some strategies or initiatives that are being implemented to address the diversity gap in rare disease clinical trials.
All rare diseases or most of them are most affected by the lack of diversity represented in their clinical trials, Rajasimha said.
"If I start with ALS, or Lou Gehrig's disease, (they're) more prevalent or better diagnosed in the western world than in the rest of the world. But even here, many patients suffer from lack of diagnosis or timely diagnosis fast enough. As with most diseases, early diagnosis is so critical for better patient outcomes and prognosis," he said.
Cystic Fibrosis and ALS are examples of diseases that are more diagnosed or prevalent in the U.S. and Europe. Other examples include sickle cell disease, thalassemia, hemophilia, blood related disorders, amino acid deficiencies, or leukodystrophies.
Rajasimha said the opportunity to look at a disease that is more prevalent in west versus the east, or vice versa, there will always be insights gathered by including other underrepresented or minority populations in the same clinical studies.
As far as efforts toward addressing this diversity gap, he mentioned the example of how the FDA now requires biopharmaceutical sponsors to include a racial and ethnic diversity plan or strategy to ensure they are engaging a diverse audience fitting for that particular disease area in clinical trials.
"Coming from the top it's very crucial," Rajasimha said. "We have seen policies and guidelines can help accelerate the change."
