The World Health Organization (WHO) has released new guidance aimed at revolutionizing clinical trials worldwide, with a particular focus on addressing health disparities among different races and ethnicities. This landmark initiative seeks to improve the design, conduct, and oversight of clinical trials across countries of all income levels, ultimately making new health interventions more accessible and affordable globally.
The guidance highlights stark disparities in clinical trial distribution, with high-income countries (HICs) hosting significantly more trials than low- and middle-income countries (LMICs). In 2022, 86 HICs conducted 27,133 trials, while 131 LMICs hosted only 24,791. This imbalance often results in LMICs being targeted for trials due to their disease burdens, but the resulting data is primarily used to authorize interventions in HICs, leaving LMICs behind.
Dr. Jeremy Farrar, WHO’s Chief Scientist, emphasized the importance of this new approach: “Strengthening country-led research and development and embedding clinical trials in routine clinical and public health services will ensure faster and more equitable access to safe and effective interventions, helping people become healthier.”
The guidance also addresses the critical issue of participant diversity in clinical trials. Recent data shows that less than 5% of trials included pregnant women, and only 13% included children. This lack of representation can lead to lower quality evidence and affect care and access to interventions for underrepresented groups.
To combat these issues, the WHO recommends putting patient, participant, and community engagement at the forefront of clinical trial organization. The guidance a
lso calls for sustainable financing to strengthen national R&D ecosystems, aiming to support better decision-making and accelerate access to health innovations globally.
This comprehensive guidance, developed in response to World Health Assembly resolution WHA 75.8, involved input from nearly 3,000 stakeholders across 48 countries. It covers trials for a wide range of health interventions, from pharmaceutical medicines to traditional or herbal measures, marking a significant step towards more equitable and effective global health research.
See “New global guidance puts forward recommendations for more effective and equitable clinical trials” (September 25, 2024)
