The World Health Organization has published new guidance aimed at enhancing the design, conduct, and oversight of clinical trials across countries of varying income levels. The new guidance looks to strengthen country-led research and development ecosystems through which safe and effective health interventions are made available more quickly around the world.
This is the first time that WHO makes detailed recommendations for national health authorities, regulatory bodies, and funders on how they can assist in ensuring clinical trials are done to give useful evidence on health interventions. Problems such as poor design of trials, diversity of participants, inadequate infrastructure, and inefficiency of bureaucracy may lead to unacceptably high human costs in terms of time consumption and monetary expenses.
There is a stark contrast in the activity level of clinical trials between the high-income countries and low- and middle-income countries. In 2022, there were 27,133 in 86 HICs, whereas in 131 LMICs, there were 24,791. Often LMICs participate in trials based on their disease burdens, but the data coming out of such trials are most commonly used to get approval for health interventions in the HICs, not in their own populations.
A statement issued by WHO read “This guidance endeavors to enhance diversity in patients in clinical trials, and the benefits of this research will therefore fall within a much larger group of people and will seem less of a one-size-fits-all approach.”
In contrast, data from 2022 showed that less than 5% of all clinical trials involved pregnant women; only 13% involved children, leading to pretty poor-quality evidence in relation to access to care for these groups. These new guidelines require the inclusion of at-risk populations from early planning stages in the design of trials and stress such safety evaluations as well as the proper mechanisms of consent.
Community engagement is highlighted as essential to the conduct of trials, in which research aligns with public needs and builds trust. Further, this guidance supports building the ecosystem for national R&D ecosystems through sustainable financing, improving capacities in making decisions with enhanced access to health innovations.
In response to World Health Assembly resolution WHA 75.8, this guidance reflects the input of nearly 3,000 stakeholders from 48 countries across trials for a wide range of health interventions-including drugs, vaccines, and non-pharmaceutical public health measures.
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