The World Health Organization (WHO) has published the Global action plan for clinical trial ecosystem strengthening (GAP-CTS) , a key implementation tool aligned with World Health Assembly resolution WHA75.8 (2022) on strengthening clinical trials. The plan outlines nine priority actions to support countries and stakeholders reform and sustain clinical trial systems that are fit for purpose, inclusive and locally led.
Anchored in WHO's 2024 Guidance for best practices for clinical trials, GAP-CTS addresses persistent disparities in trial activity and access, especially in low- and middle-income countries, and calls for systemic improvements to trial funding, design, coordination and ethical oversight.
The nine actions are designed to:
- strengthen national leadership and governance of research systems
- enhance engagement with patients, communities and the public
- address barriers faced by under-represented populations
- adopt innovative designs and digital technologies
- accelerate access to training for the research workforce
- improve regulatory and ethics review efficiency
- integrate trials into health systems and routine care
- improve research transparency via trial registries
- expand international collaboration across regions and sectors.
"Reformed research and clinical trial ecosystems will lead to more equitable access to research capacity, better trained workforces and higher quality evidence that meets local population needs," said Dr Jeremy Farrar, Chief Scientist at WHO.
To support uptake, WHO will convene partners through the Global Clinical Trials Forum (GCTF) – a WHO-managed network that facilitates peer support and knowledge exchange on implementing these actions. All stakeholders– including WHO Member States, funders, regulators, trial sponsors, patient and community engagement organizations, and research institutions – are called to align their efforts with GAP-CTS, contribute data to monitor progress and support collaborative reforms.
The GAP-CTS is designed to be used by a wide range of stakeholders, including those involved in trial funding prioritization, ethics oversight, patient and community involvement, regulation and clinical research delivery, with the goal of creating sustainable and resilient ecosystems for high-quality clinical research.
Read the full action plan: Global action plan for clinical trial ecosystem strengthening
