The World Health Organization (WHO) has published its “Guidance for Best Practices for Clinical Trials” on its official website (www.who.int). This document aims to improve the design, conduct, and oversight of clinical trials, with the goal of bridging the gap between high-income and low- to middle-income countries. The objective is to strengthen national research and development (R&D) ecosystems to accelerate global access to safe, effective, and affordable healthcare interventions.

For the first time, the guidance provides recommendations to health authorities, regulatory bodies, and funding agencies on how to optimize clinical trials, addressing issues such as poor study quality, limited participant diversity, and structural inefficiencies that hinder progress and increase costs.

Furthermore, data from 2022 show that only a small percentage of clinical trials involve vulnerable populations, such as pregnant women and children, which negatively affects the quality of evidence and access to effective treatments. The guidelines offer practical recommendations for including these populations from the early stages of trials, ensuring a prioritized evaluation of safety.

The guidelines also emphasize the importance of involving patients and communities in the planning and conduct of trials to ensure that research meets their needs and strengthens trust.

Finally, the document highlights the disparity between high-income and low- to middle-income countries in clinical trials, with the goal of addressing these inequalities through stronger national R&D ecosystems and sustainable funding.