The World Health Organization (WHO) today released guidance to improve the design, conduct and oversight of clinical trials in countries of all income levels. This guidance aims to support stronger country-led research and development (R&D) ecosystems to advance health science so that new, safe and effective health interventions can be made more accessible and affordable globally for people everywhere, faster. For the first time, WHO offers recommendations for national health authorities, regulatory authorities, funders and others on how they can best facilitate clinical trials to generate evidence on health interventions.
It addresses challenges such as poor trial design, limited diversity of participants, insufficient infrastructure and bureaucratic efficiencies, which cost time, money and lives. Global divides between high-income countries (HICs) and low- and middle-income countries (LMICs) are leading to serious inequities in clinical trials. In 2022, there were 27 133 trials taking place in the world's 86 HICs compared to 24 791 in 131 LMICs.
At times, LMICs have been targeted for inclusion in clinical trials due to their disease burdens, only for the resulting data to be used in getting health interventions authorized in HICs, but not in the LMICs. 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 .