Outbreak ready: Accelerating clinical trial site readiness in LMICS

The aim of Call 1 is for GloPID-R members to fund applications that strengthen clinical trial sites in low- and middle-income countries (LMICs), supporting the implementation of three of the actions outlined by the World Health Organization’s Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS): Action 4 (Innovation), Action 6 (Ethics and Regulatory), and Action 9: (Collaboration).

The clinical trial response to the COVID-19 pandemic was unprecedented, marked by rapid vaccine development and early therapeutic discoveries. However, the pandemic also exposed significant gaps in the global clinical research ecosystem—particularly in low- and middle-income countries (LMICs)—highlighting disparities in regional capacities to mount effective emergency responses.

The clinical trial ecosystem comprises the interconnected network of stakeholders, infrastructure, and frameworks essential for conducting high-quality research at national and international levels. In 2022, the adoption of the World Health Assembly Resolution 75.8 marked a significant global commitment toward strengthening this ecosystem. To support implementation of this resolution, the World Health Organization (WHO) has now developed the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS), which outlines nine key action areas for building more robust and resilient clinical trial systems worldwide.

Through this Global Research Improving Pandemic Preparedness (GRIPP) call, GloPID-R aims to support research funders to operationalise the agreements set by WHA 75.8 and accelerate the actions set by the GAP-CTS. Anchored in the GloPID-R Funders Living Road Map for Clinical Trial Coordination, this call seeks to the strengthen clinical trial capacity in LMICs during inter-epidemic periods by accelerating innovation, ethics and collaboration, ensuring these regions are research-ready to lead and deliver effective, equitable trials in future outbreaks.

The purpose of this topic is to support existing investments in clinical trial research made by GloPID-R members in LMICs. Proposals under this topic should aim to deliver results that are contributing to the following GAP-CTS Actions:

• Action 4: Enable effective trials through adoption of innovative designs and digital technologies
• Action 6: Improve coordination and streamlining regulatory and ethics review
• Action 9: Expand international health research and clinical trial collaboration

Proposals submitted under this call should address one of the three action areas:

• Action 4 – Innovation
• Develop standardized data protocols, including core outcome sets, to enhance data comparability in clinical research in preparation for an outbreak
• Accelerate the development of innovative, adaptive and decentralized trial designs for outbreak response, including streamlining participant recruitment and randomization at point-of-care and in communities
• Integrate digital technologies – such as information and communication technology, wearable sensors and artificial intelligence – into clinical trial to improve efficiency and quality of clinical trial across the lifecycle (e.g. recruitment, data collection and management, analysis and dissemination of results)
• Strengthening capacity and training for key stakeholders to enable the effective uptake and implementation of innovative methods, tools, and technologies in clinical research
• Establish digital systems that support transparent communication throughout research and trial activity cycles, including for data management and sharing
• Invest in machine-readable metadata and support semantic and technical interoperability between clinical trial registries

• Action 6 – Ethics and regulatory
• Support the development of clear ethics and regulatory frameworks at national level that adhere to international standards and are ready for local deployment
• Advance efficiency and harmonization between ethics and regulatory agency processes to avoid duplication, including strengthening cross-border reliance mechanisms and establishing joint reviews for trial authorization
• Strengthening capacity of national Research Ethics Committees (RECS) to enhance clinical trial review competency
• Streamline ethical review and regulatory approval procedures—such as parallel review pathways, single-point submission systems, and pre-approved, standardized open access study protocols—to reduce administrative delays during outbreaks without compromising oversight

• Action 9- Collaboration
• Harmonize health research guidelines and policies to reduce bureaucratic barriers and inefficiencies
• Support the sustaining of “always on, always warm” clinical trial networks to ensure readiness and rapid activation in response to emerging threats through international partnerships
• Facilitate collaboration across clinical trial networks and adaptive platform trials to support the use of harmonized definitions and trial endpoints and well-designed clinical trial protocols, facilitated by collaborative data-sharing platforms
• Enhancing government involvement and oversight into the ecosystem

Out of scope: developing or implementing new clinical trials.

ELIGIBILITY

To be eligible for funding under this GRIPP call, proposals must adhere to the following requirements:

1. Its content corresponds, wholly or in part, to the call scope description above, supporting GAP-CTS Action 4, 6 or 9
2. Primary benefit should be focused on LMIC(s) clinical trial ecosystem, with preference for projects that focus on low-income countrie(s).
3. Each proposal must be submitted by a consortium of applicants (institutions) (maximum 4) comprising:
   1. At least one lead applicant (institution) that is currently funded by a GloPID-R Member to conduct clinical trial(s), as evidenced by an award letter detailing the support provided and by trial registration in a trial registry conforming to WHO standards.
      1. Note: the GloPID-R member does not need to be a contributor to this current call
   2. At least one lead institution from LMIC(s), with preference for projects that focus on low-income countrie(s).
   3. For proposals focused on Action 6 (Ethics), consortia must include representation from at least one legal entity hosting national regulatory agencies and/or national ethics committees within the LMIC of project focus.

Consortium applications must identify the lead administering institution (Coordinator) and named Project Coordinator.

Institutions worldwide are eligible to participate in the projects and may request funding, however, it is expected that the majority of the project funding will be allocated to activities conducted at institutions in LMICs.

In addition to the available call budget, the South African Medical Research Council and the National Research Foundation, South Korea have agreed to provide an extra funding allowance to selected proposals that include a South African or South Korean institution. This additional funding allowance is subject to a separate funding agreement between the selected institution and the respective funding agency.