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

Abstract

In the aftermath of the COVID-19 pandemic, the structuring of a nationwide research network for preparation and response to emerging infectious diseases (EID) with epidemic or pandemic potential has become increasingly essential.

A nationwide EID operational research network (OPEN-ReMIE),is funded for five years through the France 2030 program and run by the French national research agency (ANR). Its primary missions are to accelerate hospital-based clinical research under epidemic or pandemic conditions with academic or industrial sponsors, and to pursue this effort in international research networks. OPEN-ReMIE governance is geared to steering this network and to guaranteeing its operability in inter- as well as crisis modes. It will be the point of entry for key international trial platforms, academic and private sponsors, regulatory agencies, associations of citizens and patients, and think tanks committed to promoting scientific integrity.

OPEN-ReMIE encompasses six work packages: (i) regulatory affairs, sponsoring, fast-track procedures and contracts; (ii) clinical site network management; (iii) methodology and management centers to provide methodological expertise (generic master protocols, sets of core and extended variable catalogs, electronic case reports form templates, data management and interoperability, monitoring…); (iv) laboratory and biological resource center management; (v) drug supply and pharmacovigilance supervisory board; (vi) training programs and communication plans for various stakeholders: research teams, healthcare professionals, students, associations of citizens and patients and, increasingly, civil society actors.

All in all, OPEN-ReMIE is a nationwide “preparedness task force” embedded in a large-scale European consortium for EID clinical research and working with other international EID clinical research platforms.