Collaborative Real-World Evidence Among Regulators: Lessons and Perspectives

Area of Science:

• Regulatory Science
• Public Health
• Pharmaceutical Policy

Background:

• The International Coalition of Medicines Regulatory Authorities (ICMRA) unites 38 global regulatory bodies.
• The COVID-19 pandemic highlighted the need for international collaboration on real-world evidence (RWE) and observational studies.
• Existing networks and infrastructure were leveraged to address pandemic-related research challenges.

Purpose of the Study:

• To evaluate the effectiveness of the ICMRA COVID-19 Real-World Evidence (RWE) and Observational Studies Working Group.
• To identify lessons learned from 3 years of collaborative research during the pandemic.
• To formulate recommendations for enhancing future public health emergency preparedness and response.

Main Methods:

• Focused on the ICMRA COVID-19 RWE and Observational Studies Working Group's activities.
• Conducted a member survey to gather insights and experiences.
• Analyzed collaborative outputs, including studies and policy statements.

Main Results:

• The Working Group produced impactful studies and statements on RWE and vaccine safety.
• Key lessons emphasized the importance of global collaboration, rapid decision-making governance, and network utilization.
• Recommendations were developed to strengthen international research collaboration and preparedness.

Conclusions:

• Effective communication, collaborative research, and leveraging infrastructure were crucial to the Working Group's success.
• The Working Group's experience provides a foundation for future RWE strategic entities.
• The findings contribute to improving global public health emergency response mechanisms.