Pharmacogenomics (PGx) helps assess genetic differences that affect an individual’s response to medications. While genetic disparities can impact disease prevalence, mortality and response to medication – ethnic, demographic and socioeconomic factors also contribute to the variability that is seen across populations.1 Despite the tremendous progress made in PGx research in recent decades, many studies underrepresent the diversity that exists across the U.S.2
In November 2020, the U.S. FDA issued draft guidance to increase the inclusion of individuals with different demographic (i.e., sex, race, ethnicity, age, location of residency) and non-demographic characteristics (e.g., organ dysfunction, comorbidities, disabilities and diseases or conditions with low prevalence).3 The guidance aim is to improve study diversity by reducing barriers to participation in research and clinical trials as an important step to address health disparities in personalized medicine.3
In this webinar, Dr. Ulrich Broeckel discusses the advantages of conducting comprehensive high-throughput PGx testing to accelerate the understanding and use of personalized therapies across diverse populations to reduce health disparities.
“We know that patient’s response to medications is not uniform and not every drug works for every patient. … The goal of PGx is to provide actionable data to guide drug discoveries and therapeutic decisions.”
Dr. Broeckel also describes:
- case studies illustrating the genetic differences in research studies and clinical trials,
- the use of PGx technology to identify common and rare alleles among ethnic groups,
- FDA guidance to enhance diversity in clinical trials and allelic coverage for PGx testing,3,4
- content and array performance comparisons across PGx platforms, and
- PharmacoScan™ and PharmacoFocus™ solutions provide comprehensive allelic coverage, an important consideration when investigating diverse populations.
This 31-minute in-depth educational session aims to help improve racial health disparities through better trial design and equitable participation in PGx research and clinical trials.
Interested in pharmacogenomics research? Contact us to discuss your requirements and make it easy for you to pick the right technology.
Ulrich Broeckel, MD is the CEO and Founder of RPRD Diagnostics and a Professor at the Medical College of Wisconsin. Dr. Broeckel is a leading physician-scientist with over 20 years of experience in genetics and genomics, and more than 10 years of experience in clinical diagnostics. He is an expert in translational pharmacogenomics research serving as the Professor of Pediatrics, Section Chief of Genomic Pediatrics, and Associate Director for Pharmacogenomics, Genomic Sciences, and Precision Medicine Center at the Medical College of Wisconsin.
- National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Community-Based Solutions to Promote Health Equity in the United States; Baciu A, Negussie Y, Geller A, et al., editors. Communities in Action: Pathways to Health Equity. Washington (DC): National Academies Press (US); 2017 Jan 11.
- Clark LT, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019 May;44(5):148-172.
- FDA, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry, Nov 2020.
- Guidance for Industry: Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling. Jan 2013.