Strengthening clinical trials_October 2025
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Newsletter: October 2025
From the Secretariat
This edition captures the increasing momentum as clinical research stakeholders translate commitments into collective action under the World Health Assembly Resolution (WHA 75.8). Together, we are advancing towards more inclusive, ethical, and sustainable clinical trial ecosystems that cater to every population.
Welcome
The past quarter has witnessed significant progress towards a more robust and interconnected global clinical trials ecosystem, propelled by collaboration and a shared purpose.
Global alignment is on the rise, evident in a collective statement from prominent research funders pledging their support for resilient and sustainable clinical trial systems. Accessibility has been enhanced through translations of the World Health Organization (WHO) Guidance for Best Practices for Clinical Trials into Chinese, French, and Russian languages, ensuring broader dissemination across different regions. Collaboration has strengthened with the establishment of the Global Clinical Trials Forum (GCTF), a network managed by WHO that links clinical research stakeholders worldwide.
Building upon this positive momentum, WHO is developing a practical benchmarking tool to assist research institutions in evaluating and enhancing their clinical research capabilities. Regional efforts persist in promoting the implementation of World Health Assembly resolution (WHA75.8) and the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS) throughout all WHO regions.
Collectively, these achievements signify an increasing global dedication to ensuring that clinical trials are resilient, fair, and responsive to public health needs worldwide.
Be part of the movement! Subscribe to the Global Clinical Trials Forum newsletter today! Join a growing community shaping the future of efficient and equitable clinical trials.
Global funders unite for stronger clinical trials
Aligned investment approach reshaping clinical research ecosystems
In September 2025, thirteen of the world's largest medical research funders issued a Joint Statement on Strengthening Clinical Trials, committing to implementing WHO standards that reinforce national trial systems and ensure research better serves patients and communities.
This collective pledge marks a significant alignment with the GAP-CTS and directly responds to Member States' call for strategic investment through WHA75.8.
The statement outlines commitments to:
- embed trials within national infrastructure and local priorities,
- promote inclusive trial design and community engagement,
- ensure transparency, data sharing, and timely publication, and
- develop measurable indicators to track progress collectively.
As momentum grows, the World Health Organization (WHO) invites other funders and partners to join this shared effort to transform how clinical trials are designed, conducted, and sustained globally. The aim is to promote equitable participation across countries and ensure that research responds to public health priorities and improves health outcomes for all.
WHO Benchmarking Tool for institutional clinical research capabilities
Turning feedback into country action
WHO is developing a Benchmarking Tool to support research institutions in assessing their capabilities in conducting clinical trials and related research activities. Following the completion of the consultation phase, feedback is being integrated as preparations begin for country pilots to validate the framework through discussions with institutions on the ground.
The Benchmarking tool is part of WHO’s implementation of the GAP-CTS, supporting countries in building readiness and sustainable capacity.
Expanded access: WHO Guidance for Best Practices for Clinical Trials now available in seven languages
Bringing best practices closer to every region
To promote broader adoption and fair implementation, the Guidance is now accessible in seven languages: Arabic, Chinese, English, French, Portuguese, Russian, and Spanish.
Please share this resource within your networks to support the progress of inclusive and high-quality clinical trials globally.
WHO launches Global Clinical Trials Forum
A new era of collaboration for better health evidence
A new global platform to enhance the design, conduct, and use of clinical trials for better health outcomes has been established. On 7 October 2025, WHO launched the Global Clinical Trials Forum (GCTF)-a WHO managed network that brings together diverse clinical trials stakeholders under a shared goal; to make clinical trials more inclusive, ethical, efficient and impactful.
Anchored in World Health Assembly resolution WHA75.8, and guided by the WHO Guidance for Best Practices for Clinical Trials and Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS) , the Forum provides a collaborative space where knowledge and expertise are translated into action. From improving national trial infrastructure to advancing readiness in health systems, members will collaborate through themed working groups to turn shared principles into real-world progress.
Global collaboration to strengthen respiratory research and clinical care
On 6 October 2025, WHO convened a global meeting bringing together investigators, methodologists, and patient representatives from O₂CoV2 and other acute and critical care research networks. The meeting held in Kigali, Rwanda, focused on drafting a research protocol for a platform to test pragmatic interventions aimed at reducing mortality and morbidity from respiratory infections in both adults and children.
The Global O₂ptimization of Respiratory Research Support Collaboration is an international initiative working to improve clinical care for severe acute respiratory infections and hypoxemia in low- and middle-income countries. Building on findings from the WHO O₂CoV2 study, which revealed significant gaps and inequities in access to oxygen and delivery technologies, WHO’s Safe and Scalable Care team launched an open call to establish online working groups. These groups have since defined research priorities and clinical trial governance structures to guide future work.
Regional updates
Highlights from WHO Regional Offices and Member States
Viet Nam - Charting the future of clinical trials
On 26 September 2025, WHO Viet Nam and Hanoi Medical University, with technical collaboration from WHO Regional Office for the Western Pacific (WPRO) convened a national workshop to chart the future of Viet Nam’s clinical trial ecosystem. Participants discussed findings from a recent situational analysis, introduced the GAP-CTS, and explored opportunities to streamline processes, improve quality, and expand future trial activity.
Indonesia - Strengthening clinical trial ecosystem
On 13 November 2025, the Indonesia Clinical Research Center (INA-CRC) Ministry of Health, with technical collaboration from WHO Indonesia and WHO Regional Office for the Western Pacific (WPRO) will host a national workshop, bringing together policymakers, researchers, regulators, and international partners, to shape the next phase of clinical trial development. Building on desk review findings, the discussions will spotlight policy and operational bottlenecks, highlight good practices, and examine readiness for the Benchmarking Tool pilot rollout. As a key step toward piloting, the workshop aims to align national strategies with global benchmarks while reflecting Indonesia’s unique context.
Strengthening ethics and regulatory systems
The 2025 PAHO Regional Assessment of National Research Ethics Systems report has been published. The report highlights the regional progress toward robust ethics oversight.
PAHO - Regional Template for clinical trial agreements
Following consultations and regional stakeholder input, PAHO launched the Regional Template for Clinical Trial Agreements during a bilingual virtual seminar attended by Dr Jarbas Barbosa, PAHO Director. The template, developed to harmonize clinical trial agreements and reduce start-up delays, builds on recommendations from the 2023 regional workshop on implementing WHA75.8.
The publication is currently available in Spanish, with English and Portuguese versions forthcoming.
PAHO - Guiding questions to support ethical research review
A new tool from PAHO offers guiding questions to assist Research Ethics Committees (RECs) in analysing studies involving human participants. Grounded in the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines and existing regional frameworks, it supports RECs in reviewing proposals before and during studies as part of ongoing ethics monitoring.
The resource consolidates previous PAHO publications and serves as a reference for reflection, not a checklist, encouraging deliberation tailored to each study’s context.
Resources you may want to bookmark
Making trials work for older adults
Older people are frequently excluded from clinical trials, particularly in low-resource settings. A recent review provides 120 practical recommendations to guarantee that research accurately represents aging populations.
Let us enhance the inclusivity of research by sharing these insights to influence trials that genuinely cater to aging populations.
The EUPATI Patient Expert Training Programme is a 12–14-month blended course for patients, caregivers, and advocates to strengthen their understanding of medicines development.
Portal of Clinical Trials of the Americas
PAHO’s Portal of Clinical Trials of the Americas now includes two dedicated areas for regional ethics and regulatory forums .
Webinar highlights: Catch up now!
In case you missed them, catch up on the recordings of some of the recent webinars.
Launch of the French translation of WHO’s Guidance for Best Practices for Clinical Trials
On October 9 2025, WHO launched the French version of the Guidance for Best Practices for Clinical Trials, bringing together stakeholders from Francophone countries to support its implementation under WHA75.8 resolution.
PAHO's bilingual webinar series on clinical trials
Watch the recordings on:
Regional template for clinical trial agreement (26 August)
Ethical inclusion of pregnant participants in clinical trials (13 August)
Pre-approved protocols for clinical trials: Importance and pending challenges (18 June)
Template for clinical trial contract and insurance policy: Regional proposal (4 June)
For related previous webinars, explore PAHO's Portal of Clinical Trials of the Americas.
Upcoming events
Mark your calendars and stay tuned for updates
Clinical trials on advanced therapies
October 2025.
PAHO’s Regional Program on Bioethics and Quality and Regulation of Medicines and Health Technologies will host a seminar on the challenges of conducting and regulating clinical trials on advanced therapies in the region.
South Asia Forum 2025: Advancing clinical research in cardiovascular, metabolic, and renal health
November 2025 - Colombo, Sri Lanka
The George Institute for Global Health and Remedium One will co-host the South Asia Forum 2025 in Sri Lanka on 6–7 November 2025. This biennial scientific congress convenes leading clinical researchers, regulators, and industry experts to discuss emerging trends and challenges in clinical research.
The 2025 edition will focus on advances in cardiovascular, metabolic, and renal diseases, with sessions addressing diversity and equity in clinical trials, ethical and regulatory considerations for regional and global studies, and future directions for noncommunicable disease research in South Asia.
Stay connected
Every action shared through this Forum contributes to a more efficient and equitable research future. Stay informed and stay engaged.
- Subscribe to the Global Clinical Trials Forum newsletter today!
- Contact: wha758@who.int
- Visit: Strengthening clinical trials
