Real-World Evidence for Public Health Emergencies

The ICMRA Working Group on Real-World Evidence for Public Health Emergencies was established to provide a collaborative forum for international regulatory agencies to proactively enhance the efficiency and coordination of critical responses to emerging public health emergencies through joint studies and evidence generation.

The Working Group achieves this by establishing agile governance principles and streamlined processes designed to accelerate the generation of timely evidence to support prompt regulatory action.

The Working Group works to optimise preparedness by leveraging existing infrastructures across participating jurisdictions. This approach enables members to test, refine, and maintain ‘ever-warm’ governance and operational processes, ensuring readiness to rapidly launch collaborative studies when new public health threats arise.

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Members:

 

Useful resources


ICMRA Working Group on Real-World Evidence for Public Health Emergencies – Meeting Summary (15 July 2024)
1st Working Group Teleconference

The ICMRA Working Group on Real-World Evidence for Public Health Emergencies held its inaugural meeting on 15 July, where members reviewed each agency’s real-world data capabilities and priorities and agreed on a shared mandate to support collaborative, timely evidence generation during future public health emergencies. The group confirmed that contributions to joint studies will be flexible and interest-based, and launched a call for volunteers to help develop common governance principles to guide future collaboration. The next meeting will discuss draft governance principles and potential study topics.
 

ICMRA Working Group on Real-World Evidence for Public Health Emergencies – Meeting Summary (12 December 2024)
2nd Working Group Teleconference

The ICMRA Working Group on Real-World Evidence for Public Health Emergencies met on 12 December to review and refine draft governance principles that will guide the design and conduct of future collaborative studies, including roles, feasibility assessment steps, transparency considerations, and publication practices. Members also agreed on a shared, broad working definition of “public health emergencies” to ensure the group’s approach can be applied to global health threats beyond infectious diseases. Updated governance materials will be circulated for final review, and discussions on future study topics will continue at the next meeting in March.
 

ICMRA Working Group on Real-World Evidence for Public Health Emergencies – Meeting Summary (5 March 2025)
3rd Working Group Teleconference

The ICMRA Working Group on Real-World Evidence for Public Health Emergencies met on 5 March to finalize its governance principles for conducting collaborative international studies and to discuss two new study proposals focused on vaccine safety preparedness (background rates of selected adverse events) and global utilisation of GLP-1 receptor agonists. Members agreed to a four-week period for agencies to express interest in participating in these studies, after which kick-off meetings will be arranged to refine objectives and assess feasibility. The next Working Group meeting is planned for mid-2025.


ICMRA Working Group on Real-World Evidence for Public Health Emergencies – Meeting Summary (10 July 2025)
4th Working Group Teleconference

The ICMRA Working Group on Real-World Evidence for Public Health Emergencies met on 10 July to review progress on two collaborative international studies focused on (1) background rates of selected adverse events to support vaccine safety assessments and (2) global utilisation patterns of GLP-1 receptor agonists. Participating agencies are now conducting feasibility assessments and developing shared protocols, with follow-up meetings set for July and September. The group also agreed to improve how study outputs are shared publicly and will reconvene following the ICMRA Plenary in November.
 

ICMRA statement on international collaboration to enable RWE for regulatory decision-making (2023)

 

Collaborative studies

Background incidence rates (BGRs) of adverse events of special interest (AESIs)
  • Objective(s): Generate BGRs of AESIs for public health emergencies preparedness and to support early stages of vaccine safety signal evaluation.
     
Glucagon-Like Peptide-1 receptor agonists (GLP-1 RA) drug utilisation study
  • Objective(s): Provide an overview of GLP-1 RA utilisation patterns, patients characteristics and how these have changed over the past ten years in comparison with other medicinal products used in diabetes and for weight management. The aim is to describe prescribing trends and identify determinants driving the demand for GLP-1 RAs and recent supply shortages.

 

More details on both collaborative studies will be published in the coming months.

 

Former ICMRA COVID-19 Real-World Evidence and Observational Studies Working Group

The ICMRA COVID-19 Real-World Evidence and Observational Studies Working Group was established in May 2020 to strengthen global regulatory collaboration on real-world evidence (RWE) during the COVID-19 pandemic. The group concluded its mandate in February 2024, transitioning its lessons learned and activities to the new ICMRA Working Group on Real-World Evidence for Public Health Emergencies.

Between 2020 and 2023, the Working Group focused on leveraging observational studies to inform regulatory decisions and to promote coordination on disease characterization, treatment safety and effectiveness, and vaccine surveillance. It issued key ICMRA statements highlighting the importance of international collaboration and transparent communication of COVID-19 vaccine safety and effectiveness.
 

Three main technical workstreams advanced global evidence generation:
  • The COVID-19 Vaccine Pharmacovigilance Network (VPN) shared emerging vaccine safety information and contributed to the ICMRA/WHO Vaccines Confidence Joint Statement.
  • The CONSIGN pregnancy research program pooled data from international partners to study medicine use and outcomes in pregnant women with COVID-19.
  • The Building International Cohorts initiative produced joint studies on steroid use, coagulopathy, and COVID-19 case definitions, strengthening shared data models and analytical alignment.
     
Useful resources: