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Strengthening clinical trials_January 2026 No images? Click here Newsletter: May 2026From the SecretariatGlobal commitments turning into action Welcome to the May 2026 edition of the Global Clinical Trials Forum (GCTF) Newsletter. Here we share the momentum to strengthen clinical trial ecosystems that are scientifically robust, ethical, inclusive and responsive to real public health needs. This edition highlights the launch of WHO’s new online course translating WHO Guidance into practical learning, and the piloting of a WHO benchmarking tool for clinical research institutions. Initiatives such as Ghana’s national dialogue demonstrate how global frameworks can catalyze locally led solutions, grounded in national priorities and realities. At the same time, our collective focus on equity, ensuring underrepresented populations are included, and sustainability is shaping a more forward-looking and responsive research ecosystem. Through the GCTF network, collaboration continues to be a key strength. Working groups are translating shared commitments into tangible outputs, advancing community engagement, strengthening training, and showcasing innovation in trial design. Together, these efforts are helping to build systems that can deliver more locally relevant evidence, faster, and where it is needed most. The work ahead is ambitious, but the direction is clear. By working across disciplines, sectors and regions, we can create clinical trial ecosystems that truly serve communities everywhere. We invite you to stay engaged, contribute your expertise, and be part of this global movement. Subscribe to the Global Clinical Trials Forum newsletter today! WHO Launches new online course to strengthen clinical trials globallyFrom global commitments to real-world action On 4 May 2026, WHO launched a free, self‑paced course Good Practices for Clinical Trial Design and Implementation on the WHO Academy platform, officially unveiled during a global webinar with overwhelmingly strong participation from research stakeholders across all WHO regions. What sets this course apart is its practical focus. It translates WHO Guidance for Best Practices for Clinical Trials into applied, real‑world learning, equipping participants not only with knowledge, but with tools they can immediately use across diverse trial settings. The discussion highlighted a clear intended shift in global clinical research: research embedded in care, stronger inclusion of underrepresented populations, and renewed focus on ethics, trust, and community engagement. Speakers also shared how countries are building sustainable, locally driven trial systems, moving beyond short-term projects to long-term impact. Interest has been strong since release. The course is now open and already being taken up by a wide range of stakeholders worldwide, with more than 1,900 registrations in the first 24 hours. Explore the course, share, and integrate it into your clinical trials capacity-strengthening efforts. Watch the full webinar to hear the insights shaping the future of clinical trials worldwide. WHO is piloting maturity framework to strengthen clinical research institutionsInforming the development of a new WHO tool for clinical research capacity strengthening
WHO is piloting a benchmarking tool for institutional capability in clinical trials, marking an important step toward developing a practical resource to strengthen clinical research ecosystems. The pilot is being conducted through institutional self‑assessment within research institutes and trial sites. It is testing how the tool can be applied across diverse clinical research settings to help institutions identify gaps in governance, infrastructure, workforce capacity, and quality management systems, and to inform targeted actions and investments for capability improvement. Insights generated through the pilot phase will inform further development of the benchmarking tool, ensuring it is fit for purpose and able to effectively support improvements in performance, quality, and sustainability of clinical trial conduct. Stay tuned for further updates. Global experts shaping the future of clinical research ecosystemsWHO Technical Advisory Group advances key tools and collaboration for impact On 14–15 April 2026, WHO convened its Technical Advisory Group (TAG) on Clinical Research Ecosystem Strengthening, bringing together global experts in Geneva and online to guide the next phase of work on strengthening clinical trials. The TAG plays a critical role in translating the WHO Guidance into practical implementation tools. Key areas of focus include
What stands out is the collective strength of this group, bringing together diverse expertise across regions and disciplines, to address complex challenges in clinical research ecosystems. Their insights are helping ensure that WHO’s tools are practical, relevant and responsive to real-world needs. Ghana advances national dialogue on strengthening clinical trial ecosystemsStakeholders align on priorities to build capacity, strengthen coordination and position Ghana as a regional R&D hub A three‑day national dialogue in Ghana, co‑organized by WHO and the National Vaccine Institute–Ghana (NVI), brought together key stakeholders to strengthen the country’s clinical trial ecosystem. Discussions highlighted Ghana’s strong research capacity and a regulatory system recognized at Maturity Level 4, alongside gaps such as coordination of research ethics committees and limited focus on underrepresented areas like cardiovascular disease. Participants also emphasized local manufacturing and NVI leadership as national priorities. Building on the dialogue, stakeholders are now developing a national clinical trial action plan, supported by WHO benchmarking tools, with the potential to position Ghana as a regional hub for research and development. Environmental sustainability of Clinical TrialsPromoting environmentally sustainable clinical trials is critical in the context of climate change. The ethics team at WHO HQ is undertaking a programme of work supporting members states and the wider research community to integrate value-based environmentally sustainable policies and practices into health research. As part of this work a new publication came out in February 2926 on the environmental impacts of clinical trials, outlining key considerations to integrate environmental sustainability into trial design, conduct and oversight and is available here: Clinical trials and environmental sustainability: review of key considerations to develop climate change mitigation and adaptation strategies. Additional guidance for Member States and funders to develop environmentally sustainable policies for clinical trials will be finalized in 2026. Inclusion of underrepresented populationsLeaving no one behind: WHO advances inclusive clinical trials As part of a programme of work designed to integrate equity throughout the research lifecycle, the ethics team at WHO HQ, is developing guidance on the inclusion of underrepresented and underserved populations both in research and access to the benefit of research. This is a key focus area of the Global Action Plan for Clinical Trial Ecosystem Strengthening and WHO Guidance for best practices for clinical trials. This cross-WHO initiative is building on work already undertaken with key population groups, including pregnant women, paediatric, ageing populations, migrants and people with disabilities but the next phase will expand to capture a much wider group of underrepresented populations, The work is being undertaken in 3 phases in close collaboration with Cochrane and WHO Collaborating Centres:
WHO is looking forward to engaging with the wider clinical trial community on this initiative. Transforming commitments to action through Global Clinical Trials ForumGCTF membership continues to grow The Global Clinical Trials Forum (GCTF) continues to expand as a multi‑stakeholder platform supporting the implementation of World Health Assembly resolution WHA75.8 on strengthening clinical trials. The network has now reached 40 active members, including 31 non‑State actors, and 9 States-actors, reflecting strong and growing global engagement across sectors and regions. The network includes 3 WHO Collaborating Centres (The Global Health Network, The Aga Khan University, and National University of Singapore) This diversity reinforces GCTF’s role as a platform for collaboration, knowledge exchange and coordinated action. As the forum grows, efforts will focus on deepening engagement, supporting country‑level implementation, and translating global guidance into practical impact. WHO regional office updatesAdvancing regional action, collaboration, and innovation in strengthening clinical trial ecosystems PAHO’s Clinical Trial AcceleratorAs part of World Health Day, “Together for Science”, PAHO held the virtual seminar PAHO’s Clinical Trial Accelerator. The Clinical Trial Accelerator is an umbrella initiative aimed at strengthening the number, efficiency, quality, and impact of clinical trials in the Americas. It is composed of several “engines,” some of which are already available through PAHO’s Portal of clinical trials of the Americas, as well as newly developed “engines,” such as the platforms for regulatory information and horizon scanning. PAHO’s Clinical Trial Accelerator aims to:
You can watch the recording here. Ethics of human challenge studiesOn 2 March 2026, the Pan American Health Organization (PAHO), through its Regional Program on Bioethics and its programme on the Quality and Regulation of Medicines and Health Technologies, convened a new seminar as part of its ongoing clinical trials series. The session introduced new guidance on the ethical acceptability of controlled human infection studies during public health emergencies, while exploring key challenges in applying these principles across the Region. You can watch the webinar recordings here. Related resources are available via PAHO’s Portal of clinical trials of the Americas. Updates from GCTF network membersTransforming commitments into action through GCTF NIHR strengthens equity and inclusion in global health researchNIHR is advancing equity and inclusion across its global health portfolio by promoting fair and equitable partnerships, inclusive research practices, and meaningful involvement of underserved populations. Learn more and access the Equity, Diversity and Inclusion Toolkit to support implementation in research design and delivery. Capacity Building at Clinical Trials Unit: Advancing progress in implementing the WHA75.8 resolution on strengthening clinical trials
As a WHO Collaborating Center, the Clinical Trials Unit (CTU), AKU Karachi, is committed to strengthening research capacity through global best practices in clinical trials. In 2026, CTU delivered capacity-building initiatives, including site mentorship visits for Institute of Psychiatry (IOP), virtual trainings on hepatitis testing and GCP, and academic teaching sessions. These efforts enhanced trial readiness, ethical compliance, and technical skills across diverse stakeholders. By supporting emerging research sites, frontline workers, and students, CTU promotes high-quality, decentralized research clinical trial networks, aligned with international regulatory standards and WHO priorities. Centre for IMPACT: Institute of Psychiatry Hands-on Training on Clinical Trial Conduct Virtual training for CBO Outreach Workers GCP Refresher training to Matiari Research Centre (Field team) Advancing Risk-Based Approaches in Clinical Trials: Global Symposium at Aga Khan UniversityThe Clinical Trials Unit is hosting a symposium and workshop in collaboration with WHO and DRAP on May 15th and 16th, 2026 at the Aga Khan University. This two-day event aims to strengthen understanding and practical implementation of risk-based strategies within the clinical trial ecosystem. See agenda here. Breaking language barriers: New evidence on access to cross-border pediatric clinical trials in EuropeA recent study, Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe, published in Therapeutic Innovation & Regulatory Science, highlights key barriers to trial access across Europe. Drawing on a survey of 1,436 parents in 34 countries, the study found that among families excluded from cross-border trials, 34.7% cited language barriers or country of residence as the main reason. The authors emphasize that language accommodation is both feasible and necessary, recommending it be integrated into trial design, with language used as an eligibility criterion only when scientifically justified. Innovating for children: Global leaders convene on paediatric developmentThe European Forum for Good Clinical Practice will host its 2026 annual “Better Medicines for Children” Conference, bringing together global experts to advance paediatric research. Under the theme “Collaborating to Implement Innovative Approaches in Paediatric Development,” the event will explore how new scientific advances and evolving European legislation can be translated into better outcomes for children and their families. New report summarizes recent workshop on strengthening research preparedness in East and Central Africa
In December 2025, Africa CDC, CEPI, and PATH hosted a bilingual foundational technical workshop in Kenya with approximately 80 stakeholders to initiate the development of a roadmap and consortium structure to strengthen research preparedness in East and Central Africa. With discussions about gaps and barriers, potential solutions, and inclusive partnerships, the workshop laid the groundwork for the forthcoming structure of CEPI’s Research Preparedness Program for East and Central Africa to ensure rapid, high-quality emergency evidence generation during future outbreaks. A comprehensive report on the workshop discussions and outcomes is available in English and French. SCRI-GCTF CollaborationSCRI had the opportunity to advance discussions on SCRI-GCTF collaborations on 6 April 2026 during WHO’s recent visit to Singapore.
The discussion explored how SCRI can partner more closely with WHO, including potential models for collaboration and partnership opportunities across key priority areas of the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS). SCRI is pleased to share some of our initiatives aligned with the action areas of GAP-CTS:
The Clinical Trials Singapore Portal (CTSG), launched in July 2024, is developed to cater to patients, caregivers, clinical investigators and companies by making clinical trial information more accessible and comprehensible. By demystifying the clinical trial landscape, CTSG aims to encourage greater interest in clinical trials, fostering innovation and improving health outcomes. SCRI is happy to feature GCTF content in CTSG’s upcoming newsletters as well. We look forward to continued dialogues with WHO and fellow GCTF members as we work collectively to advance the Global Action Plan and strengthen clinical trial ecosystems globally. Who will end TB? Symposium on community leadership in AmsterdamIAVI co-organized a community-led event at the KIT Institute in Amsterdam ahead of World TB Day. Entitled “Who will end TB?”, the symposium explored science, stigma, and community leadership in the TB response”. The event welcomed more than 50 advocates, researchers, students, and healthcare professionals to engage in frank reflection on the power of community leadership and the role of art and storytelling in the TB response. Participants shared a resounding call to action – communities must be prioritized as experts, decision makers, and leaders to create a TB response that works for everyone without stigma or injustice.
Vaccine evaluation in pregnant and breastfeeding women to support product information language and access. Nairobi, Kenya, 26-27 February 2026.
PATH convened global stakeholders in Nairobi to address a key challenge in vaccine development on enabling evidence-informed product information for pregnant and breast-feeding women. Participants identified several barriers, including challenges in generating pregnancy-specific data during clinical development, limited use of post-marketing evidence to update labels, and misalignment between global recommendations and national regulatory practices. There was strong consensus on the need for earlier and more deliberate inclusion of pregnant populations across the vaccine lifecycle, supported by clearer guidance, aligned incentives, and shared accountability. The convening reinforced that equitable access to vaccines requires a continued shift toward inclusive evidence generation, with coordinated action across regulators, policymakers, and developers. A meeting report is in development to capture key insights and outline the next practical steps. Strengthening clinical research ecosystems in Sri Lanka: Advancing evidence for better patient care
The University of Kelaniya has played a pivotal role in strengthening Sri Lanka’s clinical trial ecosystem over the past two decades, generating and translating evidence across multiple therapeutic areas. In the last decade, its research has focused on scalable solutions to improve blood pressure control. A landmark trial, conducted in collaboration with the The George Institute for Global Health and published in The Lancet (2024), demonstrated that a single-pill combination of three antihypertensives is more effective than standard treatment. This evidence has already influenced global practice, contributing to updated treatment guidelines and inclusion of the therapy in the 2025 World Health Organization Model List of Essential Medicines Cohort of people without TB infection enrolling in Phase 2b trial of MTBVAC vaccine candidateThe Phase 2b IMAGINE clinical trial of the tuberculosis (TB) vaccine candidate MTBVAC is now enrolling a new cohort who have not been exposed to TB infection, with first vaccination administered in February. The addition of 1,200 additional participants at 16 clinical research centers in South Africa, Kenya, and Tanzania could hold significant value for speeding the pathway to future licensure of MTBVAC. LEAP4WA wraps up, setting the scene for late-stage Lassa fever vaccine development
Over the last five years, the LEAP4WA consortium has brought together a unique multidisciplinary collaboration of seven leading research institutions in Africa, Europe, and North America to lay the groundwork for the late-stage development of an effective and accessible Lassa fever vaccine in West Africa. As the IAVI-led consortium wraps up, LEAP4WA partners can be proud of all they have achieved to advance the development of IAVI's rVSVΔG-LASV-GPC vaccine candidate. Thanks to generous support from EDCTP and CEPI, the partnership is now much better prepared—operationally, scientifically, and logistically—to support a high-quality Lassa fever vaccine efficacy trial. Read the final LEAP4WA newsletter for updates on capacity strengthening, community engagement, and dissemination activities—plus the latest student blog post! Resources to support your workA selection of guidance, tools and publications to support your work in strengthening clinical trial ecosystems WHO International Clinical Trials Registry Platform (ICTRP)The ICTRP provides a global overview of registered clinical trials, promoting transparency, accountability and access to reliable trial information. It enables users to search and link data from primary registries worldwide, supporting ethical conduct and informed decision-making in clinical research. Portal of Clinical Trials of the AmericasPAHO’s Portal of Clinical Trials of the Americas now includes two dedicated areas for regional ethics and regulatory forums . Upcoming events involving GCTF membersMark your calendar Stay connectedStrengthening clinical trial ecosystems requires collaboration across regions, sectors, and disciplines. Every contribution shared through the GCTF reflects the collective effort needed to advance ethical, inclusive, and high-quality research. We invite you to stay engaged and be part of this growing global community.
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