Rapid-sequence clinical research before and during a pandemic: Lessons learned and the way forward

Area of Science:

• Public Health
• Infectious Diseases
• Clinical Research Networks

Background:

• The COVID-19 pandemic highlighted the need for robust national research networks for emerging infectious diseases (EID).
• Existing structures required enhancement to effectively prepare for and respond to EID with epidemic or pandemic potential.

Purpose of the Study:

• To establish and describe the OPEN-ReMIE (Operational research network for EID) national network.
• To outline its mission to accelerate hospital-based clinical research under epidemic/pandemic conditions.
• To detail its role in national preparedness and international collaboration.

Main Methods:

• The network is funded by France 2030 and operated by the National Research Agency (ANR).
• It features a governance structure for operability in inter-crisis and crisis modes.
• Six work packages cover regulatory affairs, site management, methodology, laboratory resources, drug supply, and training/communication.

Main Results:

• OPEN-ReMIE is structured as a national preparedness task force.
• It serves as a central point for various stakeholders, including sponsors, regulatory agencies, and patient associations.
• The network is integrated into a larger European consortium and collaborates with international platforms.

Conclusions:

• OPEN-ReMIE is essential for strengthening national capacity in EID clinical research.
• The network aims to improve preparedness and response to future epidemic or pandemic threats.
• Its operational framework and collaborative approach are key to its success.