Clinical trials update: country action, training and practical tools
No images? Click here
GCTF quarterly: Strengthening clinical trial ecosystems
August 2026
THIS QUARTER IN CLINICAL TRIALS
This edition highlights how WHO, GCTF members and partners are translating World Health Assembly resolution WHA75.8, WHO’s clinical trials guidance and the Global action plan for clinical trial ecosystem strengthening (GAP-CTS) into practical action. Updates focus on country engagement, training, ethics and regulatory strengthening, inclusion, institutional capacity building and preparedness.
FROM COMMITMENTS TO COUNTRY ACTION
These examples show how global guidance is being translated into national capacity strengthening, priority-setting and practical improvements in trial oversight, in line with WHO guidance and GAP-CTS.
Kazakhstan Summer School strengthens national clinical research capacity
From 16 June to 16 July 2026, more than 200 researchers and healthcare practitioners took part in Kazakhstan’s clinical trials Summer School, delivered by the National Scientific Centre for Health Development with support from WHO and GCTF members.
Experts from across the network contributed to six thematic sessions, demonstrating GCTF collaboration in practice and supporting Kazakhstan’s efforts to build sustainable national clinical research capacity. The activity shows how GAP-CTS implementation can be advanced through country-focused training and member collaboration.
South Africa identifies priorities for a stronger clinical trials system
WHO and the South African Medical Research Council convened a national dialogue in Cape Town on 14–15 July 2026 to identify practical priorities for strengthening South Africa’s clinical trials system. Government, regulatory, ethics, academic and community stakeholders discussed governance, workforce capacity, institutional capability, community engagement and emergency preparedness. The dialogue helped translate WHO guidance and GAP-CTS priorities into country-level action, with a focus on stronger ethics–regulatory coordination and greater inclusion of underserved populations.
TRAINING
Training is a core enabler of GAP-CTS implementation, particularly Action 5, helping countries and institutions apply good clinical trial practices in real-world settings.
GCTF members and collaborators help shape WHO’s Clinical Trials Training Resource Hub
The GCTF Training Working Group has completed the first phase of work supporting WHO’s Clinical Trials Training Resource Hub. Members agreed quality and inclusion criteria, identified priority learning needs and tested the resource-review process. The project now moves into platform development, resource collection and user testing. As the Hub develops, members are also contributing training resources. The Singapore Clinical Research Institute has contributed its self-paced Essentials of Clinical Trials for Beginners course, which provides foundational learning in clinical trials and site-level research operations. GCTF members and partners will be invited to test the Hub before launch.
Working Group members included AVAC, CANTRAIN, Clinical Trials Centre at The University of Hong Kong, EMA, Fergus Sweeney (Ex-EMA, ICH E6, TAG member), George Institute, Institut Pasteur, Nepal Health Research Council, Ottawa Hospital Research Institute, Fundació Privada per a la Recerca i la Docència Sant Joan de Déu, St. John’s Medical College and Research Institute, The Global Health Network and WHO TDR.
PATH builds clinical study capacity for African diagnostics manufacturers
Through the Unitaid-funded Manufacturing for Diagnostics Excellence in Africa project, PATH delivered training for African in vitro diagnostics manufacturers on clinical studies for regulatory submission. The session, held in Nairobi as part of a WHO and Medicines Patent Pool technical workshop, covered when clinical performance studies are needed, evidence requirements, study oversight, protocol elements and internationally recognised principles for conducting clinical performance studies.
WHO clinical trials course reaches learners in 156 countries
The uptake indicates strong demand for accessible, self-paced learning that supports implementation of WHA75.8 to strengthen national clinical research capacity.
EFFICIENCY AND PREPAREDNESS
Efficient ethics review, regulatory coordination and emergency preparedness are essential for faster, high-quality clinical trials and for implementation of WHO guidance and GAP-CTS.
Pre-approved protocols could help research start faster during emergencies
PAHO is supporting countries to develop and review research protocols before health emergencies occur, enabling studies to start more rapidly when outbreaks emerge.
The project, part of PAHO’s Clinical Trial Accelerator and funded by CEPI, is accompanied by a short animated explainer and seminars on adaptive and platform trials and ethical preparedness.
India simplifies ethics review for multicentre research
The Indian Council of Medical Research (ICMR) has published operational guidelines for single ethics review of multicentre research and supported implementation through four webinars reaching more than 1,100 participants. The guidance clarifies roles, documentation and processes intended to support efficient and ethical multicentre studies.
The guidelines support efficient and ethical multicentre research, a core requirement for stronger clinical trial ecosystems in line with WHO guidance and GAP-CTS.
ACT EU tracks progress towards Europe’s 2030 clinical trial targets
ACT EU has published its first quarterly report on Europe’s 2030 clinical trial targets. Covering January to March 2026, the report shows early progress, including 19 multinational trials authorised above the historical average and 40.5% of trials recruiting within 200 days of application submission. The update supports stronger monitoring, transparency and coordination across Europe’s clinical trial ecosystem.
ACT EU has also published its 2026–2027 workplan and a joint response on clinical trial results publication.
INCLUSION AND PARTICIPATION
Inclusive, people-centred approaches help build trust, widen participation and make clinical research more relevant to the people and communities it is intended to serve.
New competencies aim to embed patient partnership in research teams
MRCT Center, CANTRAIN and EUPATI have developed patient-partnership competencies for potential integration into the Joint Task Force for Clinical Trial Competency Framework.
Patient partners, caregivers, researchers, study staff and industry representatives contributed to the work, providing a practical basis for more inclusive research teams.
Uganda study co-creates maternal vaccine information with communities
The PROTECT Uganda study, involving National Institute for Health and Care Research, used a participatory co-creation process to design educational toolkits to boost vaccine confidence and encourage participation in maternal vaccine trials.
Pregnant women, health workers, community influencers and policymakers helped shape the content, messages and delivery channels. These included short videos, radio spots, public address systems and antenatal health talks. The work supports more inclusive, trusted and people-centred clinical research, in line with the wider focus of WHO guidance and GAP-CTS.
Also on inclusion: The UK Clinical Research Inclusion Group, established through the UK Clinical Research Delivery programme, is developing a UK-wide roadmap to improve access to and inclusion in clinical research. The group will identify priority actions, agree milestones and support shared learning across the sector.
RESEARCH METHODS AND QUALITY
New reporting standards address the specific needs of paediatric trials
Two expert consortia, including members from the Johns Hopkins Bloomberg School of Public Health, have published new reporting standards for randomised trials involving children and adolescents.
SPIRIT-C 2026 and CONSORT-C 2026 introduce paediatric-specific requirements covering age- and development-related considerations in eligibility, outcomes, treatment effects and dosing.
MORE UPDATES
- Paediatric trial access and language inclusion: GCTF member Sant Joan de Déu co-authored two publications on cross-border paediatric trials and language barriers in paediatric research. Together, they highlight practical ways to support more inclusive participation, including coordination, language support, interpretation and family-centred trial management. Read more about cross border trials and language barriers
- Decentralised HIV prevention research in South Africa and Uganda: AHRI’s MOBILE MEN study used a purpose-built mobile research truck at a busy taxi rank to improve access to oral and long-acting injectable PrEP among men who travel for work. The Phase 3b implementation-effectiveness trial shows how decentralised trial models can reach underserved populations while maintaining high-quality clinical oversight. Read more
- Clinical research capacity and practice uptake in Sri Lanka: The University of Kelaniya Clinical Trials Unit held a scientific meeting for young researchers and a multisectoral forum on translating GMRx2 hypertension trial findings into routine healthcare practice. The activities connected clinical research capacity-building with policy, regulation, equitable access and implementation of effective treatment. Read more: Scientific meeting in Jaffna | Translating trial findings into practice
- GCP readiness and multilingual training resources: The University of Hong Kong Clinical Trials Centre delivered an ICH E6(R3) Good Clinical Practice training series that reached more than 1,000 attendances and helped site teams prepare for strengthened GCP implementation in Hong Kong. HKU-CTC also contributed to the Chinese-language version of TRREE’s ICH-GCP R3 module, expanding access to training on quality, participant protection, data governance and risk-based trial conduct. Access TRREE in simplified Chinese or other languages.
- Risk-based approaches and GCP readiness in Pakistan: The Aga Khan University supported activities on risk-based clinical trial strategies, ICH GCP E6(R3) readiness and implementation practice in Pakistan, including the 2nd Clinical Trials Summit of Pakistan. The activities strengthened practical understanding of risk assessment, quality management and good clinical practice. Read symposium highlights
- AI in clinical trials: The George Institute for Global Health and the University of Bordeaux convened researchers, industry and regulators to examine emerging uses of artificial intelligence in trial design, conduct and interpretation. Symposium information.
- Academic cancer trials: EORTC convened investigators and patients from multiple regions to inform a forthcoming Lancet Oncology Commission on the public-health role and challenges of academic clinical trials and networks. Read the article.
GCTF OVERVIEW
A growing global platform for collaboration
USE, WATCH AND PARTICIPATE
Use
WHO International Clinical Trials Registry Platform (ICTRP)
Explore clinical trials registered worldwide through WHO’s ICTRP Search Portal. The portal supports transparency, helps users follow research activity across countries and health areas, and contributes to stronger clinical trial planning and decision-making.
Portal of Clinical Trials of the Americas
Explore PAHO’s Portal of Clinical Trials of the Americas for tools and regional initiatives supporting stronger, more transparent and better coordinated clinical trials across the Region.
Participate
Comment on language inclusion in paediatric trials
EnprEMA has opened a public consultation on draft recommendations to prevent language exclusion in cross-border paediatric clinical trials in Europe. The recommendations focus on practical ways to reduce language and logistical barriers that can limit access to trials, especially for children with rare diseases who may need to participate across borders. Feedback is invited from trial sites, investigators, sponsors, research networks, patient organisations and families.
Deadline: 30 September 2026
COMING UP
Mark your calendar
Ecraid and ESCMID will hold the fifth edition of this postgraduate course from 6 to 8 October 2026 in Verona, Italy. The course supports early-career researchers in clinical microbiology and infectious diseases to strengthen study design, methods and reporting, with topics including pragmatic trials, causal models, predictive AI and target trial emulation.
STAY CONNECTED
Have an update to share? GCTF members are invited to submit short news items on strengthening clinical trials, with relevant visuals and links for future quarterly editions. Contributions should focus on work completed in the previous three months or activities planned for the next three months.
- Forwarded this newsletter? Subscribe to Global Clinical Trials Forum newsletter!
- Contact: wha758@who.int
- Visit: Strengthening clinical trials
- Share your feedback
