Recent Trends in Drug Safety: The Growing and Evolving Role of Real-World Evidence White Paper

Recent Trends in Drug Safety: The Growing and Evolving Role of Real-World Evidence

Historically, major drug safety issues have driven the evolution of regulatory frameworks, particularly in the post-approval period. Recently, real-world evidence (RWE) derived from real-world data (RWD) has become crucial in the post-authorization supervision of medicines. This shift is influenced by a broader regulatory context addressing evidence needs throughout drug development and life cycle management. This paper outlines the evolving landscape of safety studies, explores recent regulatory guidelines from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and provides insights into shifts in the regulatory environment, evolving approaches with RWD, the implications for post-approval research, and future expectations for post-marketing safety studies.

Authors:

• Delphine Saragoussi, M.D., MScPH, executive director, strategic and scientific affairs, real-world evidence
• Sara Angleman, Ph.D., MPhil, senior research associate, strategic and scientific affairs, real-world evidence
• Katheryne Downes, Ph.D., MPH, research scientist, strategic and scientific affairs, real-world evidence
• Debra A. Schaumberg, ScD, OD, MPH, vice president and head, strategic and scientific affairs, real-world evidence