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. To track progress and capture wider shifts in norms and standards, a supplementary progress report will be released on an annual basis.
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.
To monito
r the implementation of the actions recommended in the Roadmap, we will be releasing regular ‘progress reports’. Our first progress report outlines the current state-of-play, an analysis of GloPID-R’s readiness to mount an effective clinical trial response and recent shifts in norms and standards since the publication of the Roadmap.
The first objective of the report is to describe the current state of play of implementation of the recommended actions within the Roadmap, to showcase best practices and highlight areas of weak implementation across funders in the GloPID-R coalition. This will inform tailored implementation support to be developed in the subsequent year. To capture progress, data were collected from publicly available sources by the GloPID-R Research and Policy team to produce pre-populated ‘self-assessment tools’ for supplementation and validation by GloPID-R members funding clinical trials. This section of the report aims to provide readers with a comprehensive overview of the funding and policy landscape.
The second objective of the report is to quantify GloPID-R’s readiness to support an effective clinical trial response to an outbreak over time, by assessing key indicators of impact. Indicators for the first progress report were developed by the GloPID-R Research & Policy Team, based on readily available data from the Pandemic PACT program and the ‘self-assessment tool’ in line with the three key goals of the roadmap. Indicators for the second progress report will be developed in consultation with the GloPID-R Clinical Trials Working Group. This section aims to give readers an evaluation of the progress the GloPID-R coalition has achieved, toward the impact goals it has set.
The final objective of the report is to outline new shifts in norms and standards for funding clinical trials. A key ongoing lever for change in funding of trials is the WHO’s work to implement the World Health Assembly Resolution on strengthening clinical trials (WHA 75.8). This section of the report aims to outline the implications these shifts have for research funding organisations and signposts work to support funders in meeting best practice standards.
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.