Strengthening clinical trials_January 2026
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Newsletter: January 2026
From the Secretariat
Happy New Year, and welcome to the January 2026 edition of the Global Clinical Trials Forum (GCTF) Newsletter.
As we look ahead to 2026, this edition reflects a year of meaningful progress in strengthening clinical trial ecosystems worldwide. Together, Member States, researchers, funders, regulators, civil society, and patient communities have continued to translate WHA75.8 commitments into practical action by expanding access to WHO guidance, aligning funding policies, and deepening cross-regional collaboration
This issue looks back at key milestones from 2025 and ahead to priority actions for 2026, highlighting how Global Clinical Trials Forum working groups are turning global standards into real-world impact. From global commitments to collaborative action and country-level implementation, it showcases how partners worldwide are strengthening ethical, inclusive and high-quality clinical research in diverse settings.
Thank you for being part of this growing global community. Your engagement and collaboration remain essential as we continue building clinical trial systems that respond to public health needs and serve communities everywhere.
2025 in review: Building momentum for 2026
In 2025, significant progress was made in advancing the implementation of WHA75.8 and strengthening clinical trial ecosystems globally. Key milestones included expanding access to WHO guidance, launching new tools and networks, and aligning partners around shared priorities for ethical, inclusive, and high-quality clinical trials.
Looking ahead to 2026, with your continued support, WHO will work closely with Member States and all partners to further strengthen clinical trial ecosystems and expand equitable access to high-quality research worldwide. The following activities are planned for 2026:
- Piloting a benchmarking tool for institutional clinical trial capability to help institutions identify gaps and strengthen capacity across the full trial lifecycle.
- Drafting potential progress indicators for national clinical research ecosystems.
- Establishing the WHO clinical trial training resource hub: a global training platform bringing together curated, accessible learning resources to support the application of best practices in clinical trials.
- Engaging Global Clinical Trials Forum (GCTF) network members: continued collaboration through working groups, webinars, and knowledge -sharing activities connecting diverse stakeholders including Member States, researchers, regulators, funders, private sector and civil society to support implementation of WHO Guidance and strengthen cross-regional partnerships.
Together, these efforts aim to ensure that clinical trials are ethical, inclusive, and responsive to the needs and priorities of communities everywhere.
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WHO reconstitutes Technical Advisory Group to strengthen global clinical research ecosystems
Expert guidance to support implementation of WHO clinical trials norms and standards worldwide
WHO has reconstituted its Technical Advisory Group (TAG) on Clinical Research Ecosystem Strengthening to advance the implementation of the Guidance for Best Practices for Clinical Trials and support new normative work that strengthens clinical research systems worldwide.
The TAG provides expert advice on tools and approaches that improve the quality, coordination and impact of clinical research, with a strong focus on low- and middle-income countries and underrepresented populations. Its diverse expertise supports WHO’s goal of ensuring that every country can generate and use high-quality clinical evidence.
WHO launches new global research agenda for paediatric clinical trials
Alongside strengthening systems and governance, WHO continues to shape the future evidence agenda for under-represented populations
Strengthening evidence generation to improve child health worldwide
WHO has published a new technical report outlining a global research agenda to address critical evidence gaps in paediatric clinical trials, particularly for children aged 0–9 years. Responding to the call in the WHO Guidance for Best Practices for Clinical Trials to better include under-represented populations, the agenda prioritises research questions where clinical trials can have the greatest public health impact, especially in low- and middle-income countries.
Developed through an inclusive process involving more than 380 stakeholders worldwide, the agenda identifies 172 priority research areas across infectious diseases, noncommunicable diseases, newborn health, nutrition, and early childhood development. It also highlights the importance of regional collaboration, integration of research into national health systems, and sustained investment to ensure evidence generation leads to real improvements in child health.
Why this matters: By prioritising paediatric research where evidence gaps are greatest, this agenda helps ensure clinical trials deliver meaningful health benefits for children, particularly in low- and middle-income countries.
WHO developing a new online course to strengthen clinical trial design and implementation
Translating key scientific and ethical considerations into practical skills for high-quality and impactful clinical trials
To support the uptake of the WHO Guidance for Best Practices for Clinical Trials, WHO has developed a new interactive online course based on Section 2 of the Guidance (Key scientific and ethical considerations for clinical trials).
The course is designed to strengthen practical skills for planning and conducting ethical, scientifically robust and context-appropriate clinical trials. It also encourages informed, risk-proportionate decision-making across the trial lifecycle.
It is currently being piloted with a selected group of stakeholders ahead of its official launch.
Stay tuned for the launch news.
From Global commitments to action through GCTF Working Groups
Updates from Global Clinical Trials Forum working groups translating global commitments into practical action for clinical trial ecosystem strengthening
Leading global research funders align around shared priorities
The Joint statement of research funders Working Group delivered its primary output in October 2025 with the publication of the joint statement on strengthening clinical trials. Developed through targeted roundtable discussions with national and international funding agencies, the statement sets out shared commitments to embed community engagement, inclusion of underrepresented populations, transparency through trial registration and data sharing, and alignment with national priorities into funding policies and practices.
The statement has been endorsed by a growing group of funders (14), with mechanisms in place to support continued endorsement and collective monitoring of progress.
What’s next: Within six months, signatories will develop a set of measurable indicators to track progress and strengthen accountability across the research community.
Strengthening informed consent practices globally
The Global consensus on best practices for informed consent Working Group has completed a draft consensus manuscript developed by research ethics and regulatory experts. Now under final review, this work represents an important step toward harmonising simplified informed consent language to improve comprehensibility and supporting ethical, participant-centred clinical trials across diverse settings.
What’s next: The manuscript will be submitted for journal publication and wider dissemination.
Measuring what meaningful engagement looks like
The Community engagement outcome measures and landscape Working Group is addressing a long-standing gap in how participant and community engagement in clinical trials is defined, assessed, and strengthened. The group has aligned on core principles, identified key conceptual gaps, and agreed to develop practical monitoring and evaluation metrics.
What’s next: The group will advance the development of practical Monitoring and Evaluation (M&E) metrics for effective participant and community engagement in clinical trials and is launching a stakeholder mapping survey to better understand existing actors, initiatives, tools, and practices in this area. Findings from the survey will help inform and strengthen the development of these metrics and guide future collaborative efforts.
Showcasing innovation in trial design
The Exemplar innovative clinical trial design Working Group is working on case studies that highlight innovative approaches can make trials more feasible, effective and efficient. The identified real-world examples will aim to highlight the good practices of adopting innovations in various research contexts. The examples will be shared through GCTF and WHO channels and potentially adapted to training materials.
What’s next: The group is reviewing study synopses and will invite more contributions of diverse innovative approaches.
Identifying training resources for the WHO clinical trial training resource hub
The Training Working Group draws on GCTF members’ expertise and experience to support expansion of the training materials. The group started mapping roles and competencies corresponding to the good practices outlined in the Guidance, identifying criteria to ensure the training materials be accessible and curating available materials from the network members that can benefit broad stakeholders and learners, especially in LMICs
What’s next: The group will complete the mapping exercise and curate materials for the WHO clinical trial training resource hub, tailored to the needs of different stakeholder groups.
Regional updates
Highlights from WHO regions demonstrating progress in governance, ethics, and trial capacity.
Intercountry consultation on strengthening regional capacity for clinical trials in the Eastern Mediterranean Region
The Department of Science, Information and Dissemination at WHO EMRO hosted an intercountry consultation on national capacity and governance for large-scale clinical studies, especially Randomized Controlled Trials (RCTs) in Cairo from 3–4 September 2025. Dr Arash Rashidian, Director of department attended the meeting and guided the discussions.
Seventeen experts from 14 countries in the region, from ministries of health and academia, contributed their extensive experience to guide efforts to strengthen RCTs and the broader clinical trial ecosystem. The discussions culminated in a set of key recommendations.
Through panel discussions and group works participants highlighted strengths and weaknesses of the regional and national clinical trials ecosystem. They highlighted the needs in ethics governance, regulatory systems, workforce capacity, and infrastructure, exchanging experiences and practical solutions. The meeting emphasized harmonizing processes to strengthen the clinical trials ecosystem, investing in training, and leveraging digital technologies and artificial intelligence (AI) to enhance clinical trial efficiency and inclusiveness.
The participants endorsed the creation of a regional clinical trials network, stronger partnerships, and alignment of national systems with global standards. Recommendations target both the WHO and Member States to build sustainable, high-quality, and equitable clinical research ecosystems across the Eastern Mediterranean Region.
Landscaping the clinical trial ecosystem in the Eastern Mediterranean Region
In 2024-25, the Department of Science, Information and Dissemination at WHO EMRO conducted an in-depth review of the region’s clinical trial ecosystem, highlighting the strengths, gaps and areas for improvement. The study helped identify actionable strategies to enhance capacity and align it with global standards. The work analyzed trends in clinical trial publications and registered trials, and reviewed country-specific infrastructure and regulations.
The disparity was evident in the peer-reviewed publication area, where, between 2013 and 2023, four countries (Iran, Egypt, Saudi Arabia, and Pakistan) accounted for more than 80% of publications (total number 11,686). Key barriers included fragmented regulatory frameworks, limited private-sector engagement in clinical research, inconsistent ethical oversight, and underrepresentation of vulnerable populations in clinical trials.
The strategic recommendations included strengthening governance and funding, expanding infrastructure and training of the health workforce, ethical oversight and transparency, harmonizing the regulatory process, fostering collaboration and partnerships, and promoting equity and inclusivity.
Strengthening research ethics and governance in the Eastern Mediterranean Region
WHO EMRO supported a workshop in Syria in 2025 on building national capacity for research ethics, clinical ethics, streamlining ethics of clinical research and overall strengthening of national and sub-national ethics review committees.
Strengthening national capacities for Randomized Controlled Trials (RCTs)
The Ministry of Health in Qatar expressed a strong interest in strengthening its capacity to conduct RCTs in line with the national health priority results conducted in 2026.
Launch of the Arabic version of clinical trial guidance
The Arabic version of WHO’s Guidance for Best Practices for Clinical Trials, was launched during the intercountry consultation in September 2025.
This initiative represents a key step toward broader regional adoption of the guidance, with a focus on strengthening the design, conduct, and oversight of clinical trials.
The guidance aims to enhance trial efficiency and quality, minimize research waste, and support the development of resilient, sustainable clinical trial systems that are capable of operating effectively during public health emergencies as well as in routine endemic settings.
Strengthening clinical trials for better health - Indonesia
On 13 November 2025, the Indonesia Clinical Research Center (INA-CRC) of the Ministry of Health, with technical collaboration from WHO Indonesia and the WHO Regional Office for the Western Pacific (WPRO), convened a national workshop in Jakarta on strengthening the clinical trial ecosystem.
The workshop brought together policymakers, regulators, researchers, patient groups, and industry partners to discuss policy, regulatory, and capacity challenges, while sharing lessons from across the region. Discussions highlighted how WHO frameworks can support Indonesia in expanding high-quality, multi-country clinical trials.
Agreed next steps for 2026–2027 include piloting the WHO Clinical Trial Unit Maturity Framework, strengthening trial registries, expanding the clinical trial workforce, and broadening research across priority disease areas, laying the foundation for a stronger and more accessible clinical research ecosystem in Indonesia.
Updates from GCTF network members
Latest updates and activities from Global Clinical Trials Forum members showcasing how their work is contributing to stronger, more resilient clinical trial ecosystems worldwide. These highlights reflect GCTF members’ own initiatives that advance the shared goal of strengthening clinical research ecosystems.
People’s Research Agenda: 2025 update on community-driven HIV research
In 2025, AVAC released the first annual update of the People’s Research Agenda (PRA), building on work developed in partnership with global advocates and communities throughout 2024. The PRA sets out a people-centred framework for how HIV prevention products should be developed, tested, and introduced to better reflect the needs and realities of those most affected by HIV.
The 2025 update introduces a new interactive format, including an actionable tracker, advocacy toolkit, and clear calls to action for funders, researchers, advocates, communities, and policymakers supporting coordinated, community-driven progress in HIV prevention research.
Empowering patients in research
EUPATI is a non-profit, multi-stakeholder training academy that supports meaningful collaboration between patients and researchers across the medicines research and development lifecycle. Through free, accessible resources including the EUPATI Toolbox, Open Classroom e-learning platform, and the Patient Expert Training Programme, and through initiatives like EUPATIConnect and EUPATI Learning Lab, EUPATI helps strengthen patient involvement and advance health innovation together.
Enhancing the clinical trial ecosystem in Nepal: Progress and prospects
In recent years, the Nepal Health Research Council (NHRC) has continued to strengthen Nepal’s clinical trial ecosystem through reforms in governance, capacity building, and international collaboration. Building on its early role in reviewing the country’s first clinical trials and issuing national clinical trial guidelines, NHRC has expanded training in research ethics, invested in digital systems, and aligned its work with international best practices.
Key advances include:
- regular capacity-building activities for researchers and ethics committees,
- development of an integrated online platform for trial, researcher, and ethics committee registries in collaboration with WHO, and
- active engagement in global networks such as the Global Clinical Trials Forum (GCTF).
NHRC is also revising its national clinical trial guidelines to align with the WHO Guidance for Best Practices for Clinical Trials, with a focus on streamlined approvals, strengthened quality standards, and improved participant protection.
Through growing collaboration with regulators, researchers, and community partners, these efforts are helping create a more ethical, transparent, and responsive clinical research environment—positioning Nepal to contribute meaningfully to regional and global clinical research.
Explore NHRC ethics resources and partnerships
Centralized management of clinical study agreements in Hong Kong
Since April 2025, Hong Kong’s Hospital Authority (HA) which manages all 43 public hospitals has implemented a new clinical study agreement management scheme with the professional support from The University of Hong Kong Clinical Trials Centre (HKU-CTC).
Industry sponsors can establish their agreement templates with the HA based on the standardized version for use across study sites at all public hospitals. Study‑specific agreements are handled through a central and streamlined process, offering a single point of contact, faster execution, and acceptance of electronic signatures.
This approach supports more efficient initiation of industry‑sponsored studies and contributes to strengthening Hong Kong’s capacity for high‑quality clinical research.
Updating clinical trials regulations in the United Kingdom
Amended clinical trials regulations will come into force in the UK on 28 April 2026. The Health Research Authority (HRA) has been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to update the regulations.
The HRA and MHRA have published a suite of guidance to support researchers and sponsors in the lead up to the regulations coming into effect. To support a smooth transition, we’re encouraging the clinical trial community to read our guidance and start planning for the changes now.
Explore the updates to the regulation and access the guidance.
Building better research services in the UK
The Health Research Authority is building Plan and Manage Health and Care Research, a single, integrated service that will replace legacy systems and provide the digital platform for every stage of planning, approving, setting up, managing and completing research across the UK. Keep up-to-date with this work by subscribing to the building better research services newsletter
Advancing inclusion and diversity in clinical research.
The Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) are working together to help researchers to improve the diversity of participants in their research. We've developed a draft set of questions and supporting guidance for researchers to consider when they design clinical trials and clinical investigations.
The answers to these questions will form the basis of an Inclusion and Diversity Plan. This will help make sure clinical research is designed to include people who could be impacted by the findings, and that people underserved by research are not overlooked.
In 2024 we held an informal consultation on the draft questions and guidance. The aim of our informal consultation was to gather feedback from sponsors and researchers on the clarity of our draft guidance and where we could provide further guidance or support in developing an Inclusion and Diversity Plan.
The feedback we received in the informal consultation has been used to create an updated second draft of the guidance. A pilot of the second draft of the guidance was launched in May 2025 in which sponsors and researchers were asked to volunteer to develop a Plan and submit it as part of an application for review by a Research Ethics Committee.
Following the close of the pilot at the end of 2025, we will now take some time to review the feedback received and consider next steps for the draft guidance.
Advancing domestic financing for vaccine clinical trials in West Africa
Between September and October 2025, ministers of health from 11 West African countries pledged a joint commitment to advance vaccine development and readiness for Lassa fever, signalling growing domestic leadership in financing clinical trials.
Building on this momentum, IAVI, CEPI, and the West African Health Organization (WAHO) co-organised a high-level discussion at the World Health Summit on sustainable financing, access, and clinical development for Lassa fever vaccines.
Why this matters: Domestic financing and regional collaboration are critical for ensuring that vaccine trials respond to local health priorities and lead to timely, equitable access for affected communities.
Advancing Lassa vaccine development: Results from an early-phase trial
In November 2025, results from a Phase 1 clinical trial of IAVI’s Lassa virus vaccine candidate were published in the New England Journal of Medicine. The CEPI-funded study showed that a single dose generated strong and durable immune responses with an acceptable safety profile.
The trial enrolled 114 volunteers in Liberia and the United States, with Phase 2a trial results from West Africa expected in 2026.
Transforming how clinical trials are designed and delivered
Protas is working to strengthen clinical trials through smarter trial design, effective use of data and technology, and collaborative policy development. In 2025, Protas supported the development of 15 clinical trial protocols across multiple disease areas, representing over one million potential participants.
The team also launched Cantata, a new trial management platform now supporting the world’s largest clinical trial in chronic kidney disease across 18 countries. In addition, Protas designed and delivered a Phase IIa hypertension trial using mobile units to reach communities typically underrepresented in research.
Resources you may want to bookmark
A curated selection of tools, guidance 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 Americas
PAHO’s Portal of Clinical Trials of the Americas now includes two dedicated areas for regional ethics and regulatory forums .
Regional template for clinical trial agreement
This regional template for clinical trial agreements outlines essential clauses and key legal considerations to help research institutions, sponsors, and investigators streamline trial initiation and ensure clinical trials are conducted in line with international ethical and regulatory standards. Available in English, Portuguese and Spanish.
Umbrella review protocol on public and patient involvement with children and families
A protocol for an umbrella review to assess the current evidence on public and patient involvement (PPI) in health and social care research with children, young people, and families. The review will identify gaps in existing approaches and help define future priorities to support more consistent, evidence-based, and meaningful collaboration with these groups in research.
Key criteria for the ethical acceptability of controlled human infection studies
This guidance outlines key ethical criteria for conducting controlled human infection studies during public health emergencies, supporting ethical decision-making and responsible research practice. Available in English and Spanish.
Questions to guide the ethics analysis of research involving humans
This resource provides key questions to guide the ethical analysis of research involving humans, supporting ethics committees, researchers, and reviewers in assessing studies in line with international ethical standards. Available in English, French, Portuguese, and Spanish.
Involving young people and families in reporting guidelines for paediatric trials
A new case study examined the experiences and impact of involving young people and family caregivers in developing reporting guidelines for paediatric randomised controlled trials. As end-users of paediatric research, their involvement helped ensure that issues important to children and families were reflected in study reports. The study addresses a gap in existing guidance and demonstrates how meaningful engagement can strengthen the relevance and quality of research reporting.
A new advocacy brief – HIV prevention at a crossroads
IAVI and the International AIDS Society (IAS) released a new advocacy brief ahead of World AIDS Day 2025, highlighting the value of sustained investment in HIV vaccine research. The brief underscores how continued investment can accelerate HIV prevention while also strengthening broader vaccine development ecosystems.
Addressing barriers to equitable access and sustainable financing for future TB vaccines
A new report from the Finance and Access Working Group of the TB Vaccine Accelerator Council presents a first-of-its-kind analysis of the barriers, bottlenecks and market dynamics that could affect timely, equitable and sustainable access to future TB vaccines. IAVI contributed to this work as a key stakeholder of the TB Vaccine Accelerator Council.
Webinars and meetings highlights
Catch up on selected highlights from recent regional and global discussions
Pan American Health Organization (PAHO): Bilingual virtual seminar series on clinical trials
PAHO hosted a series of bilingual virtual seminars in late 2025 exploring key issues in clinical trials, including the use of artificial intelligence in ethics review, evolving concepts of vulnerability in research, and clinical trials on advanced therapies. The seminars brought together diverse perspectives to support ethical, innovative, and inclusive research practices, with recordings available in English.
For related webinars and learning materials, explore PAHO's Portal of Clinical Trials of the Americas, which features 45 online training resources covering different stages of the clinical trial process and tailored to diverse audiences.
Responsive Engagement for Advancing Community and Health Research in Asia (REACH Asia)
On 8–9 December 2025, ADVANCE-ID brought together experts and partners to discuss practical approaches to meaningful community engagement in clinical trials. Discussions focused on inclusive community advisory groups, co-design of trial protocols, effective risk communication, and sustaining engagement over time. Community hubs from Thailand, Malaysia, and Taiwan also shared challenges and solutions from their local contexts.
Catch on the webinar recording
ADVANCE-ID Thailand: First community advisory group meeting (17 November 2025)
ADVANCE-ID’s Thai Public Engagement Hub, led by the Institute of HIV Research and Innovation, convened its first Community Advisory Group meeting under the Promoting Community Engagement in Clinical Trials in Asia project. The meeting brought together policymakers, patient advocates, healthcare professionals, and clinical trial teams to strengthen trust, improve understanding, and embed community perspectives throughout the clinical trial process, marking an important step toward more inclusive and people-centred research in the region.
Strengthening collaboration to advance clinical trials in Indonesia
In early December 2025, the ADVANCE-ID team visited key clinical research institutions in Jakarta, including Rumah Sakit Nasional Dr. Cipto Mangunkusumo, OUCRU Indonesia, and the Indonesia Clinical Research Center (INA-CRC). Discussions focused on strengthening collaboration across government, public, and industry sectors to advance clinical trials in Indonesia and support sustainable, high-quality research.
Advancing cancer treatment optimisation in Europe
On 24 September 2025, European Organisation for Research and Treatment of Cancer (EORTC) and Cancer Patients Europe (CPE) convened a hearing at the European Parliament to examine challenges and solutions for optimising cancer treatment in Europe.
Discussions highlighted the risks of overuse of anti-cancer medicines and the need for independent, academic-led clinical trials such as treatment optimisation and de-escalation studies, to improve patient outcomes while reducing unnecessary side effects and avoidable healthcare costs.
TB vaccines and policy impact | Union World Conference on Lung Health
At the Union World Conference on Lung Health (18–21 November 2025, Copenhagen), IAVI experts shared insights on advancing TB vaccine development, including modelling for vaccine introduction, integrated prevention strategies, and the role of global collaboration. Discussions also underscored the need for regional leadership and innovative financing to support equitable access to new TB vaccines.
African leadership in HIV vaccine R&D | IAS–IAVI advocacy series
In November 2025, IAVI and the International AIDS Society launched an advocacy series to mobilise support for African-led HIV vaccine research. The first webinar highlighted leadership and capacity built through early-phase trials in Kenya, Uganda, Zambia, and South Africa, and explored how locally driven research ecosystems can be strengthened amid shifting global priorities.
Africa regulatory conference (AfRC) webinar series: Advancing clinical research in Africa
Convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Africa Regulatory Conference (AfRC) webinar series brought together patients, communities, regulators, researchers, ethics bodies, civil society, and industry leaders to explore inclusive, innovative, and impact-driven approaches to strengthening Africa’s clinical research ecosystem. Discussions focused on patient engagement, inclusion, streamlined oversight, innovation, and regional capacity.
The series featured more than 40 speakers and attracted over 1,200 registrants per session, with a truly global audience (70% from Africa, 22% from Europe, 8% from Asia, and 2% from South America).
Webinar 1: Patient and community engagement in clinical trials
Webinar 2: Under represented populations in clinical trials
Webinar 3: Innovative clinical trial designs and digital technologies
Webinar 4: Streamlining regulatory and ethics approvals
Stay connected
Every contribution shared through the Global Clinical Trials Forum reflects the collective effort required to strengthen clinical trial ecosystems worldwide. By working together across regions, sectors, and disciplines, we can continue translating global commitments into ethical, inclusive, and high-quality research that responds to real public health needs.
We invite you to stay engaged and be part of this growing community as we continue advancing ethical, inclusive and high-quality clinical trials that serve communities everywhere.
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