Strengthening clinical trials_June 2025
No images? Click here
Newsletter: June 2025
Welcome
The second quarter of 2025 marked a pivotal moment for the global clinical trials community. With the launch of the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS), we are shifting gears, from global commitments to concrete actions. This plan sets out clear priorities that will guide countries and partners in strengthening their clinical trial ecosystems through collaboration, equity, and innovation.
This edition also spotlights the outcomes of the second Global Clinical Trials Forum (GCTF25), which brought together over 150 stakeholders from around the world to align on World Health Assembly resolution 75.8 implementation strategies and share lessons across borders. The expanding Global Clinical Trials Forum (GCTF) network continues to fuel this momentum, connecting researchers, regulators, policymakers, funders, and patient/community engagement advocates in a shared mission to elevate the quality, inclusiveness, and coordination of clinical trials nationally and globally.
The WHO Guidance for Best Practices for Clinical Trials is now more accessible. Spanish and Portuguese versions, translated and launched by Pan American Health Organization (PAHO) on 6 May 2025, are now available. The French version, adapted and translated by the Regional Office for Eastern Mediterranean Region is also available, with the launch planed for 3 September 2025. Arabic, Russian, and Chinese translations will be available soon. These efforts reflect our collective commitment to inclusivity and multilingual engagement in clinical research strengthening.
Together, we are building not only stronger systems, but a stronger sense of global solidarity. Let’s turn ambition into impact by coalescing around clinical research strengthening.
Be part of the movement! Subscribe to the Global Clinical Trials Forum newsletter today!"
Second Global Clinical Trials Forum (GCTF25) meeting: 2-3 April 2025
GCTF25: From a shared vision to action
The Second WHO Global Clinical Trials Forum (GCTF25), held in Geneva on 2–3 April 2025, marked a strategic inflection point in the global effort to reform clinical trial ecosystems. Under the theme Action for Impact, the Forum brought together over 100 stakeholders from across WHO regions, including governments, regulators, funders, ethics bodies, patient and community advocates, academia, and industry.
The Forum launched the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS)—a practical, country-driven roadmap structured around nine action areas to implement the WHO Guidance for Best Practices for Clinical Trials and advance WHA75.8. Discussions emphasized embedding trials into health systems, strengthening national leadership, ensuring inclusion, and fostering meaningful community engagement. Country examples highlighted whole-system approaches, and participants stressed the importance of long-term investment in capacity, infrastructure, and innovation.
GCTF25 laid the foundation for coordinated, stakeholder-owned action and reaffirmed WHO’s role as convenor and technical partner. The GCTF network will continue supporting implementation, tool development, and knowledge exchange to scale up best practices globally. Stay tuned for the meeting report to be published soon.
Global action plan for clinical trial ecosystem strengthening (GAP-CTS) is now available
A roadmap for stronger, smarter clinical trials
Following months of collaborative consultations, the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS) is now available. The plan outlines clear and time-bound actions to guide national and regional efforts to strengthen clinical trials ecosystem and infrastructure. Reformulated from the WHO Guidance for Best Practices for Clinical Trials, the GAP-CTS presents a practical roadmap to strengthen clinical trial ecosystems and address long-standing barriers in design, funding, ethics, regulation, capacity, and community engagement. It calls on all stakeholders to implement nine mutually reinforcing actions:
Strengthen local leadership and national support;
Enhance engagement with patients, communities and the public;
Address barriers to participation by under-represented populations;
Enable innovative trial designs and digital technologies;
Accelerate access to fit-for-purpose training;
Improve coordination and streamline ethics and regulatory review;
Integrate trials into health systems;
Step up use of registries for transparency; and
Expand international collaboration.
Towards smarter Tuberculosis (TB) trials: Countries lead the way
Towards efficient and pragmatic TB treatment trials
In September 2024, WHO brought together national TB programme managers, regulators, researchers, funders, and community voices from six high-burden countries to chart a new path for efficient and pragmatic tuberculosis treatment trials. With strong consensus, participants supported establishing a multicountry clinical trial platform focused on shorter, simpler, and more person-centred regimens for drug-susceptible TB, particularly ones that are safe, accessible, and effective across all populations, including children and pregnant women. The platform is intended to streamline regulatory processes, align with national priorities, and deliver high-quality, real-world evidence to inform future WHO guidelines.
WHO Guidance now available in Spanish and Portuguese. Other languages coming soon
To support broader access and implementation, the WHO Guidance for Best Practices for Clinical Trials is being translated into all six official WHO languages.
The Spanish and Portuguese versions, adapted and translated under the leadership of PAHO, were officially launched on 6 May 2025. These translations are now available to support more inclusive and multilingual engagement in strengthening clinical trial ecosystems globally.
The Arabic, Russian, and Chinese versions will be published soon.
Regional updates
A round up of some of the ongoing work in the World Health Organization Regional Offices and Member States
New European Union (EU) ‘Trial map’ launched
Bringing clinical trials closer to patients
The European Union has launched the ‘Trial Map’, a dynamic, easy-to-use tool that helps patients and health care professionals explore clinical trials taking place across the EU. This marks a major stride toward transparency and inclusion in clinical research.
Released in early March, the map pulls real-time data from the Clinical Trials Information System (CTIS) and allows users to search trials by country, condition, or treatment. It’s designed to make clinical research more accessible, understandable, and patient-centered, thereby supporting better engagement and decision-making for all.
Strengthening clinical trials in the Eastern Mediterranean Region and moving forward (June-September 2025)
Building on its regionais landscape mapping, the Regional Office is advancing efforts to strengthen the national clinical trials ecosystem in the Eastern Mediterranean Region. EMRO has also planned an inter-country capacity-building workshop in September 2025 for drug regulatory authorities, clinical researchers, and national bioethics committees, aimed at streamlining processes, fostering collaboration, and facilitating knowledge sharing among these groups. Furthermore, a manuscript analyzing ten years of clinical trials in the region based on WHO ICTRP data has been submitted to a peer-reviewed journal.
2025 Regional assessment of national research ethics systems report is out
The report highlights the region's progress in achieving the indicators of national research ethics systems.
Resources You may want to bookmark
The portal of clinical trials of the Americas is freely accessible
The Portal of clinical trials of the Americas, created by Pan American Health Organization, supports scientifically and ethically sound clinical trials in the region as part of World Health Assembly resolution on strengthening clinical trials (WHA75.8) implementation. The portal provides key resources and guidance to strengthen clinical research.
Visit the portal today to access tools and updates that empower better clinical trials.
This short AI-generated audio offers a quick and accessible snapshot of the WHO Guidance for Best Practices for Clinical Trials.
Webinar highlights: Catch up now!
In case you missed them, catch up on the recordings of some of the recent webinars.
PAHO's series of seminars focused on clinical trials (recordings in English)
Why and how to promote collaboration in health research? (27 February): https://www.youtube.com/watch?v=lIe5HpkEf6E
New guideline for Good Clinical Practice: E6(R3) (18 March): https://www.youtube.com/watch?v=_myYjHHCUEc
How to promote more and better clinical trials in Latin America and the Caribbean? (6 May): The virtual seminar included:
A presentation by Ludovic Reveiz (Chief of PAHO's Unit of Science and Knowledge for Impact, Department of Evidence & Intelligence for Action in Health) on key actions to revitalize the clinical trials ecosystem based on the Regional Workshop held as part of the implementation of the resolution WHA 75.8
A presentation by Vasee Moorthy (Senior Advisor, R&D, Research for Health, WHO) on WHO Guidance for best practices for clinical trials, which was launched in Spanish and Portuguese
A panel on regional challenges and possible solutions to strengthen clinical trials, including Carla Saenz (PAHO's Regional Program on Bioethics), Patricia Saidón (PAHO's Unit of Quality and Regulation of Medicines and Health Technologies), Francisca Rodríguez (Chilean Chamber of Pharmaceutical Innovation) and Luis Felipe Reyes (University of La Sabana and Oxford University).
The recording of the webinar is available from https://youtu.be/D1p3HI7MT20
PAHO's series of seminars on human genetics for health
Research and regional collaboration in oncology and personalized medicine (6 February): https://www.youtube.com/watch?v=C3DOrBnZxwQ&list=PL6hS8Moik7kv9DpCoO0mVrVC8m_d3e6a7&index=5&t=58s
For related previous webinars, explore PAHO's Portal of Clinical Trials of the Americas.
Upcoming events
Don’t miss these key gatherings shaping the future of clinical research. Mark your calendars and stay tuned for updates
Launch of Arabic and French translations of WHO Guidance for Best Practices for Clinical Trials
The French translation of the WHO Guidance for Best Practices for Clinical Trials will be launched on 3 September 2025, with the Arabic version to follow shortly after. These translations aim to enhance global accessibility and support effective implementation worldwide. Stay tuned for more information.
Stay ahead in clinical trials! Subscribe to the Global Clinical Trials Forum newsletter today!"
