The first iteration of the Roadmap was published in May 2023 and is publicly available.
Setting out clear goals, principles and recommendations, the Roadmap represents a valuable tool for funders and other stakeholders. It will support funders to improve global capacity to deliver coordinated, effective, and equitable clinical trials in response to epidemics and pandemics. This is a ‘living’ document that will be updated annually to reflect best practice.
To date, the following listed organizations endorse the Goals and Principles of the GloPID-R Living Roadmap for Clinical Trial Coordination:
The GloPID-R Research & Policy Team is looking forward to receiving more endorsements from GloPID-R members and observers.
The World Health Assembly (WHA) 75.8 Resolution on strengthening clinical trials encourages research funding agencies to prioritize and fund clinical trials that are well-designed and well-implemented, conducted in diverse settings which include all major population groups the intervention is intended to benefit.
In the wake of the COVID-19 pandemic, GloPID-R worked with both researchers and funders to co-develop a Roadmap to support funders as they implement the commitments made to strengthen the coordination of trials.
GloPID-R has had a clinical trial focus since 2017, with a dedicated working group formed in response to the Zika outbreak. Building on this foundation of expertise, our funders’ coalition undertook a 15-month process to produce the Roadmap. This effort was spearheaded by the GloPID-R Clinical Trials and Data Sharing Working Groups with the support of the GloPID-R Research and Policy Team. They worked closely with senior representatives of international clinical trial networks and observers, including CEPI and WHO.
A globally consultative and iterative approach was applied to develop the Roadmap. Researchers and funders from around the world shared their experiences of coordinating clinical trials during outbreaks through a survey, in-depth interviews and a two-day workshop. The recommended actions draw on decades of lessons learnt from world leaders in both funding and delivering trials during an outbreak.
For more information, please contact isabel.foster@ndm.ox.ac.uk
The Roadmap defines 3 goals supported by 11 principles for funders to endorse, and a set of recommended actions to uphold these principles. While not all funders will be able to implement all the recommended actions, it is expected that they should be able to act on some of them, contributing to ensuring that clinical trials are conducted equitably to benefit populations globally.
On October 24, 2023, during GloPID-R’s annual General Assembly, the Roadmap was highlighted in a dedicated session featuring presentations and a panel discussion with a focus on next steps, funder alignment, ethical research prioritization and implementation of the Roadmap in various regions of the globe.
The PEARLES scoping review builds on prior work by GloPID-R that was published in Open Research Europe on September 7, 2023. GloPID-R has received funding to update this review and identify remaining and new political, economic, administrative, regulatory, logistic, ethical, and societal (PEARLES) challenges and solutions for implementation of clinical research responses to high-consequence infectious diseases outbreaks. Members of the GloPID-R Research & Policy team have refined the study protocol and are submitting the PEARLES 2.0 protocol for publication. The scoping review is expected to be completed soon.
In addition to core support from the European Union, these initiatives received specific funding from EDCTP (on behalf of UK DHSC) grant number CSA2022GloPID-R-3387.
The GloPID-R Secretariat is a project which receives funding from the European Union’s Horizon Europe research and innovation programme under grant agreement No 101094188.