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 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: