The World Health Organisation (WHO), on Wednesday unveiled new guidance aimed at improving the design, conduct, and oversight of clinical trials worldwide.
This initiative seeks to strengthen country-led research and development (R&D) ecosystems, making safe and effective health interventions more accessible and affordable across all income levels.
For the first time, WHO provides specific recommendations for national health authorities, regulatory bodies, and funders on facilitating clinical trials.
In a statement made available to Africa Health Report, WHO’s Chief Scientist,Dr. Jeremy Farrar stated, ” Strengthening country-led R&D and embedding clinical trials in routine public health services will ensure faster, equitable access to safe interventions.”
He noted the importance of improving participant diversity, stating, “We must decisively move away from a one-size-fits-all approach.”
Current disparities are stark: in 2022, there were 27,133 trials in high-income countries compared to just 24,791 in low- and middle-income countries (LMICs). Often, LMICs are included in trials due to their disease burdens, but the data primarily benefits high-income nations.
The guidance also addresses significant gaps in representation, noting that less than 5% of clinical trials included pregnant women and only 13% involved children. This lack of diversity compromises the quality of evidence and can lead to hesitancy in accepting health recommendations from underrepresented groups.
