WHO issues guidance to boost clinical trials, speed health innovation

The World Health Organization (WHO) issued guidance on how to enhance the organization and supervision of clinical trials in nations with diverse income levels. This guidance seeks to enhance country-led research and development ecosystems in order to progress health science and make new, safe, and effective health interventions more accessible and affordable worldwide, quickly.

WHO has issued guidelines for national health authorities, regulatory bodies, funders, and others on how to support clinical trials in order to gather evidence on health interventions. It deals with issues like inadequate trial planning, lack of participant diversity, insufficient infrastructure, and bureaucratic inefficiencies, resulting in wasted time, resources, and lives.

Serious inequalities in clinical trials are being caused by the global disparities between high-income countries (HICs) and low- and middle-income countries (LMICs). In 2022, 27,133 trials occurred in 86 high-income countries, while 24,791 trials took place in 131 low- to middle-income countries. Sometimes, LMICs are selected for participation in clinical trials because of their high disease rates. However, the data obtained is often used to approve health interventions in HICs rather than in the LMICs themselves.

“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,” said Dr Jeremy Farrar, WHO’s chief scientist. “This new guidance aims to improve the diversity of trial participants to ensure research benefits the broadest range of people possible, decisively moving away from a one-size-fits-all approach.”