Outbreak ready: Accelerating clinical trial site readiness in LMICS

The aim of Call 1 is for GloPID-R members to fund projects 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 strengthen clinical trial capacity in LMICs during inter-epidemic periods by accelerating innovation, ethics and collaboration, ensuring low-resource settings 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 should aim to strengthen the clinical trial ecosystem by delivering results that contribute to the following GAP-CTS Actions:

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

While proposals may add value to ongoing clinical trial initiatives, the expected outcomes must go beyond the support of individual trials and contribute to the strengthening of the clinical trial ecosystem more broadly.

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

1. 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

Applications focused on integration of technology under Action 4 will be required to clearly demonstrate how the project intends to benefit the clinical trial ecosystem, not just an ongoing individual trial, and to articulate how sustainability will be achieved, including secured or potential long-term funding, technology transfer, and concrete plans for ongoing maintenance of technology.  Proposals should also promote local ownership to support the project’s long-term sustainability.

2. 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 through training or operational evaluation
• Streamline ethical review and regulatory approval procedures—such as parallel review pathways or single-point submission systems—to reduce administrative delays during outbreaks without compromising oversight

Applications focused on Action 6 are encouraged to make use of the WHO Global Benchmarking Tools for ethics and regulatory agencies, and to provide a detailed description of how their project intends to progress their system towards an improved benchmark.

3. Action 9- Collaboration

• 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 harmonised definitions and trial endpoints and well-designed clinical trial protocols, facilitated by collaborative data-sharing platforms
• Support initiatives for enhancing local government support and involvement in oversight into the clinical trial ecosystem

Out of scope: projects seeking to develop or implement new clinical trials (pre-clinical); projects focused on clinical trials for non-communicable diseases

Projects funded under this call for proposals should:

• Build on existing investments in clinical trial research made by GloPID-R members in LMICs
• Strengthen LMIC trial sites readiness to lead and implement high quality clinical trials in response to emerging health threats
• Advance LMIC clinical trial ecosystem in the areas of innovation, ethics and regulatory oversight, and collaboration

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 at least one of GAP-CTS Action 4, 6 or 9
2. Primary benefit should be focused on the clinical trial ecosystem in LMIC(s)
3. Each proposal must be submitted by a consortium of organisations (minimum 2, maximum 4) including:
   1. One organisation currently funded by a GloPID-R Member¹ to conduct a clinical trial(s) (phase I-III) focused on (re-)emerging diseases of epidemic potential.
      • The funder does not need to contribute to this call but must be one of the 35 GloPID-R members.
      • Clinical trial verification must be provided through a funding award letter and trial registration in a WHO-compliant registry.
      • Defined as high-priority pathogens outlined in the ‘Pathogens prioritization: a scientific framework for epidemic and pandemic research preparedness’ report
   2. At least one organisation from an LMIC
   3. For proposals under Action 6 (Ethics), the consortium must include at least one legal entity hosting a national regulatory authority and/or ethics committee in the LMIC concerned.

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

In the event of a high volume of applications, applications will undergo an initial review by a panel of experts. Applications not selected for full review will not proceed for full evaluation.

Participating funders of Call 1 will contribute up to a total budget of 2 million euros in line with the following requirements:

Consortium applicants that meet the above eligibility criteria may request funding, however, applicants are strongly encouraged to observe the funder specific requirements and align their applications accordingly for the best chances of funding.  

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

Submission and evaluation procedure

This is a single-stage application procedure. Proposals must be submitted by 24:00 on 15 November 2025 via the grants portal EDCTPgrants. Applicants need to register as users to submit an application. Evaluation results are expected to be made available by February 15, 2026.

Evaluation, scoring and thresholds

Following an admissibility and eligibility check, proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria of Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.

The following aspects are considered under the evaluation criteria:

1. Excellence

The following aspects will be taken into account, to the extent that the proposed work corresponds to the call topic description and fit with the scope and objectives of GloPID-R:

• Importance, relevance/pertinence and clarity of the objectives
• Soundness of the concept and credibility of the proposed approach/methodology
• Extent that the proposed activities will advance the mission of GLoPID-R
• Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge

2. Impact

The following aspects will be considered:

• Likelihood of achieving specific and measurable advances in GAP-CTS Action 4, 6 or 9
• The extent to which the outputs of the proposed work would contribute to the objectives of GloPID-R
• Contribution to strengthening capacity for epidemic preparedness and response, and clinical trials capacity in LMICs
• Effectiveness and quality of the proposed measures to exploit and disseminate the project results, to communicate the project activities to different target audiences nationally and internationally
• Compliance with Open research principles and FAIR data sharing

 3. Quality and efficiency of the implementation

The following aspects will be considered:

• Demonstrated value addition to existing activities funded by GloPID-R member(s)
• Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables
• Appropriateness of the management structures and procedures, including risk management, and how responsibilities for project data quality and sharing, and security will be met
• Composition and complementarity of the project participants in terms of expertise, experience and operational capacity to conduct the activities and in gender balance
• Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role
• Feasibility and appropriateness of the methods and project management to achieve the objectives within the timeframe of the project (24 months)
• Compliance with national and international standards, Good Clinical Practice, ethics and safety-related issues

Financial provisions

Projects may request between a minimum of 100,000 EUR and a maximum of 500,000 Euros, inclusive of an acceptable overhead rate based on the overhead policy of the lead administering organisation up to a maximum of 8%.

Grant agreement

The Coordinator and all participating organisations must sign a grant agreement with the funding agency within three months of receipt of the evaluation outcome letter. Failure to comply with the timelines will result in the withdrawal of the award.

Data sharing

GRIPP awardees are expected to align their data sharing practices with those outlined in the  GloPID-R Roadmap for Data Sharing as well as the associated GloPID-R Principles of Data Sharing in Public Health Emergencies (Timely, Ethical, Accessible, Transparent, Equitable, Fair, Quality).

In the case of a public health emergency, such as a public health emergency of international concern (PHEIC) in accordance with the WHO or a public health emergency under applicable national frameworks and regulations, grantees must deposit relevant project data and associated metadata in a trusted repository applying the principle as open as possible and as closed as necessary and in line with the FAIR and CARE principles. Data should be deposited as soon as its quality is appropriately assured, and at most within one month of acquisition.

Application process

• The application must be submitted online via EDCTPgrants
• Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible.

For all questions about this call for proposals, please contact: edctpgrants@edctp.org.