3070.0 - Ethical considerations for the equitable utilization of real-world data for pharmacovigilance and regulatory science activities

Session: Principled Posters: Ethics Research & Calls to Action Addressing Health Disparities

Program: Ethics

Time: 10:30 - 11:30 AM

Presenter:

Kyle Hampson

Laura Bothwell, PhD, MA

Abstract

Introduction: The expanding role of real-world data (RWD) in the drug approval and safety monitoring processes has posed new questions in regulatory science. RWD has recently been used to change drug labeling and shows promise in the detection of drug safety signals. However, the use of large real-world data sets in regulatory decision-making brings key ethical requirements—that data is scientifically valid, fairly acquired, inclusive, and representative of the diverse populations that will ultimately use the drugs post-approval. Several ethical principles are critical in guiding the responsible use of real-world data making regulatory decisions.

Methods: A literature review was conducted to identify information regarding ethical principles for the use of RWD in pharmacovigilance activities and regulatory decision-making. Relevant articles were selected for inclusion.

Findings: The ethical principles embodied in public health practice should guide all areas of RWD use for regulatory science. The principals of respect for persons, respect for privacy, and continual informed consent are critical in the responsible use of RWD sources. Additionally, data extraction techniques should be designed with an equity lens that ensures the inclusion of diverse populations. As RWD will be used to create real world evidence that can significantly influence regulatory actions, it is essential to critically examine the origins of the data included in repositories and extracted from medical records.

Conclusions: As the use of RWD is adopted into decision-making, ethical principles must inform responsible use of data to create a healthier nation for all people.