Some of the world's largest funders of medical research have committed to implementing WHO standards to strengthen clinical trial systems globally, marking a significant step toward creating a more coordinated and equitable research ecosystem. The joint statement, signed by major funding organizations, sets out comprehensive measures to integrate clinical trials into sustainable national infrastructure, improve trial design, ensure representative trial populations, and embed best practices on transparency, data management and public engagement.
Building on WHO's Global Framework
The initiative builds on the momentum of WHO's recently launched Guidance for Best Practices for Clinical Trials and the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS). The statement also draws on the 2017 WHO joint statement on public disclosure of results from clinical trials and the 2023 Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) funders' roadmap for clinical trial coordination.
Adopted against the backdrop of the World Health Assembly resolution on strengthening clinical trials (WHA 75.8), the statement recognizes the pivotal role of funders in shaping a clinical trial ecosystem that delivers trustworthy evidence, improves efficiency and ensures equity in access to research benefits.
Embedding Trials in Sustainable Systems
The statement emphasizes the importance of embedding clinical trials within national health and research infrastructure while aligning them with local priorities. Funders pledge to build on existing resources where possible, support the development of capacity where it is lacking, and ensure early engagement with communities and patients.
Recipients of funds for clinical trials will receive direct support to meet best-practice obligations, including data management, patient and community involvement, and ensuring that trial populations are representative. This approach aims to create sustainable trial capabilities that meet local needs within existing health systems.
Enhanced Trial Design Standards
Under the new commitments, trials must be well designed, address gaps in evidence, and include the populations most likely to benefit. Applicants will be expected to demonstrate how their proposals involve patients and communities, include diverse participants, and are guided by systematic reviews.
Funders will review trial designs to ensure they are appropriate, practical and generalizable, requiring applicants to set out plans for responsible data management and sharing. This systematic approach aims to reduce research waste and ensure that clinical evidence better reflects the needs of diverse populations.
Transparency and Accountability Measures
The funders committed to ensuring that trials are conducted to the highest international standards. This includes registering trials in publicly accessible registries, updating results within 12 months of completion, and publishing protocols, statistical analysis plans and findings in open-access journals.
Funders further agreed to encourage timely sharing of interpretable results during public health emergencies and support data sharing in line with international standards. These transparency measures respond to the ethical imperative of building trust among trial participants and the public.
Global Coordination and Progress Tracking
By aligning policies and practice, research funders aim to create a more coordinated global trial ecosystem. The commitments are expected to reduce duplication, improve efficiency in use of funds, and ensure that clinical evidence better reflects the needs of diverse populations.
Within six months, signatories will develop a set of high-level, measurable indicators to track collective progress. These indicators will help assess how far funders are delivering on their commitments and provide a framework for accountability across the research community.
International Leadership Perspectives
Dr. John-Arne Rottingen, Chief Executive of Wellcome, emphasized the critical importance of community engagement: "Clinical trials are a critical part of getting interventions and products to the people that need them most, as well as increasing our understanding of health conditions and diseases. Without representation and engagement with the communities affected, the products and policies resulting from clinical trials risks deepening disparities."
Professor Steve Wesselingh, Chief Executive Officer of Australia's National Health and Medical Research Council, highlighted the collaborative nature of the initiative: "To ensure NHMRC remains a world leader in clinical trials, we are committed to working with our global funders of health and medical research on implementing agreed standards that will improve the clinical trial operating environment, ensuring a more robust, consistent and efficient international approach to best practice for clinical trials."
Dr. Paul Hébert, President of the Canadian Institutes of Health Research, stressed the importance of patient involvement: "Patient and community involvement is essential to building trust and ensuring that clinical trials are impactful and reflect the needs of those they serve, while transparency helps us reduce research waste."
The initiative represents a coordinated effort to address longstanding challenges in clinical research, including lack of diversity in trial populations, insufficient transparency in results reporting, and inadequate integration of trials within national health systems. Through this collaborative approach, funders aim to create a more effective, equitable, and responsive global clinical trial ecosystem.
