Newsletter:  February 2025

Welcome 

As we dive into 2025, we bring you the latest updates and insights from the world of clinical research. This quarter’s edition highlights the ongoing dissemination and adaptation of World Health Organization (WHO) Guidance for best practices for clinical trials and the development of WHO maturity framework for clinical trial unit, designed to strengthen clinical research ecosystems worldwide.

We also provide a round-up of news and innovations from WHO Regional Offices and clinical research partners, showcasing progress and opportunities across diverse regions. Let’s continue working together to build resilient, equitable, and impactful clinical trial systems globally.

Stay ahead in clinical trials! Subscribe to the Global Clinical Trials Forum newsletter today!"

WHO clinical trials maturity unit framework 

WHO clinical trial unit maturity framework: Strengthening research ecosystems.

In May 2022, the World Health Assembly adopted resolution WHA75.8, urging decisive actions to strengthen clinical trial ecosystems. The resolution emphasizes the need to foster equitable capacity development and improve the clinical trial environment. Responding to this call, WHO developed the Guidance for best practices for clinical trials, a comprehensive resource created in collaboration with a 16-member Technical Advisory Group and a diverse range of stakeholders, including researchers, regulators, patient/community advocates, and representatives of ethics committees.

Building on this shared commitment, WHO is driving progress by developing the maturity framework for clinical trial unit, a practical tool to turn this vision into reality. 

Key objectives of the maturity framework

The framework can empower Member States and research institutions to:

• Assess and benchmark capacity
• Map stakeholders and fill gaps
• Strengthen governance and coordination

National health research authorities, which oversee clinical research policies and regulations, will find the framework especially valuable.

Seamless integration with existing WHO tools

The maturity framework complements other WHO resources, including:

• The WHO tool for benchmarking research ethics oversight
• The WHO global benchmarking tool (GBT) for national regulatory  systems

By combining these three tools, Member States can take a comprehensive approach to strengthening their clinical trials systems.

Shaping the future of clinical trials: launch of WHO-Lancet Global Health Series on 28 March 2025

On 28 March 2025, the World Health Organization and The Lancet Global Health will launch a new Series, Shaping the Future of Clinical Trials: Building an ethical, efficient, and equitable ecosystem. The Series includes seven papers that builds on the World Health Assembly resolution WHA75.8 and WHO Guidance for best practices for clinical trials (2024), addressing urgent challenges in engagement, inclusivity, trial design, regulatory efficiency, and infrastructure.

Call for game-changing clinical trials

Clinical trials have transformed healthcare, saving millions of lives. Yet, critical gaps remain in areas like cardiovascular disease, cancer, infectious diseases, and mental health. The World Health Organization is calling on patients, researchers, industry, and communities to propose key randomized clinical trials (RCTs) that could revolutionize clinical care and public health.

We seek structured suggestions for impactful trials—whether testing new interventions, repurposing existing treatments, or improving health system delivery. Proposals will be shared at the Global Clinical Trials Forum (a WHO managed network) meeting in April 2025.

Submit your ideas and help drive the next breakthrough in global health! 

You can read more about the call here.

Regional updates 

A round up of some of the ongoing work in the World Health Organization Regions and Member States 

Western Pacific Regional Office and the Institute for Clinical Research (under the National Institutes of Health Malaysia) collaborate on national stakeholder consultations to strengthen Malaysia’s clinical trial ecosystem

In September and November 2024, the Institute of Clinical Research Malaysia with support from World Health Organization Regional Office for the Western Pacific consulted with national stakeholders to identify opportunities and priorities to strengthen the clinical trial ecosystem in Malaysia. The participants in these consultations included researchers, bioethicists, clinicians, representatives from research management organizations and industry associations.  

The identified priority actions include:

• Strengthening ethical guidance to inform approval processes in anticipation of emerging and innovative trial processes, including multi-country trials.
• Building local research capacity and creating an enabling environment to support clinician-researchers
• Expanding outreach and education programs to enhance public awareness and participation in clinical trials, especially in underrepresented groups
• Encouraging partnerships between government, academia and private sector stakeholders to foster clinical trial innovations and resource-sharing

A shared goal is to strengthen an enabling environment contributing to more equitable clinical trial ecosystems in the Region. This will enhance the healthcare system through robust research and ultimately improve patient outcomes.

Strengthening the clinical research and ethics ecosystem in Lao PDR

From 16-18 December 2024, the National Ethics Committee for Health Research (NECHR), with support from WHO organized a stakeholder consultation workshop and training on research ethics to strengthen the clinical research ecosystems in Lao PDR. 

Participants consisting of senior management, policymakers, clinicians, and researchers, called for:

• Capacity building emphasizing scientific thinking and research methodology
• Opportunities for strengthening science communication for researchers and training for bioethicists on emerging health research topics
• Creating a regional network for clinical trial research that facilitates knowledge exchange and collaborative opportunities among researchers at both global and regional levels.

As a follow up, WHO shall support Lao PDR researchers to develop a case study highlighting good practices for community engagement in trials involving young children. Other possible collaborations include, piloting the WHO clinical trial online training module in Lao PDR, co-creating modules to train researchers on developing digestible research finding briefs for various stakeholders, and engaging with WHO Collaboration Centres in the Region to support ongoing capacity-building in clinical trials and research ethics.

Read more about the workshop 

Some essential resources  

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.

Clinical trial registration in International Clinical Trials Registry Platform (ICTRP)

Explore the importance of registering clinical trials in WHO's International Clinical Trials Registry Platform (ICTRP) through this informative infographic.

Research oversight

Explore the distinctions between ethics oversight for research and regulatory oversight, which applies to specific clinical trials, in this clear and concise infographic.

Webinar highlights: Catch up now!

In case you missed them, catch up on the recordings of some of the recent webinars. 

Research integrity and responsible conduct of research (November 2024)

Dive int the principles and practices that ensure research integrity and ethical conduct in clinical trials.

Research contracts and insurance policies for clinical trials: Regional challenges (December 2024)

Explore Americas regional complexities in contracts and insurance for clinical trials.

WHO launches new clinical trials guidance – What do I need to know? (December 2024)

Co-hosted by The Global Health Network and WHO, this session covered embedding research within health systems, fostering diverse and active research networks, and prioritizing community interaction throughout the trial lifecycle. Recordings in English, French,  Portuguese  and Spanish, are available.

Upcoming events 

Don’t miss these key gatherings shaping the future of clinical research. Mark your calendars and stay tuned for updates

The future of clinical trials is evolving—be part of the conversation!

Join the launch of the WHO–Lancet Series on clinical trials on 28 March 2025. 

Second WHO Global Clinical Trials Forum: Action for impact

The 2nd WHO Global Clinical Trials Forum will convene on 2–3 April 2025 at WHO Headquarters in Geneva, Switzerland. This event, with invitations balanced by geography and gender, will officially launch the Global Clinical Trials Forum (GCTF), a WHO-managed network designed to drive the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS).

Key objectives include sharing the draft clinical trial unit maturity framework, finalizing the GCTF workplan for 2025–2026, agreeing on measurable outcomes, and fostering collaboration among key stakeholders to strengthen clinical trial ecosystems globally. Participants will include representatives from research institutions, national ethics agencies, research funders, regulatory agencies, patient and community engagement groups, and the private sector.

Stay tuned for updates and outcomes from this landmark event as WHO and its partners take collective action to strengthen the clinical trials environment and infrastructure worldwide.

Stay ahead in clinical trials! Subscribe to the Global Clinical Trials Forum newsletter today!"