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Clinical trials across the world need to be designed better and take into consideration a larger variety of population groups in order to be effective, the World Health Organization (WHO) highlighted September 25, 2024. The United Nations health agency released a guiding document to make trials more scientifically robust and equitable irrespective of economic and social disparities.
Right now, there is a stark divide in the quality and quantity of trials being done in high-income countries (HIC) and low- and middle-income countries (LMIC), according to WHO. "In 2022, there were 27,133 trials taking place in the world’s 86 HICs compared to 24,791 in 131 LMICs," the document noted.
Moreover, the lack of representation of certain vulnerable population groups make the results of trials weak and unreliable.
Pregnant women, for instance, were studied in less than 5 per cent of clinical trials, WHO said referring to 2022 data. Only 13 per cent included children, it added. "This has lowered the quality of evidence, affecting care and access to interventions."
This gap limits treatment for these population groups and also makes them lose confidence in health recommendations, the global health body noted.
The document will guide national health authorities, regulatory authorities, funders and others address challenges such as poor trial design, limited diversity of participants, insufficient infrastructure and bureaucratic efficiencies.
It recommends "putting patient, participant and community engagement at the heart of organising clinical trials, to ensure that research planning, delivery and dissemination meets public needs and maintains trust".
Sustainable financing should be prioritised to strengthen research and development ecosystems in countries. This will aid in accelerating access to health innovations, WHO added.
"To fulfil their potential, they need to be reliably informative, ethical and efficient, and answer scientifically important questions relevant to the populations they are intended to benefit," according to the recommendation document.
To achieve this, WHO suggests the use of randomisation and blinding / masking of intervention allocation to minimise bias and strengthen the confidence of outcomes.
It also places a lot of importance on selecting the appropriate trial population, both in terms of diversity and size. Health authorities must enable tests on pregnant and lactating women as well as those of childbearing age. Paediatric trials are also vital to ensure a comprehensive outcome.
In order to strengthen the clinical trial ecosystem, WHO has defined four pillars that must be taken into account during planning. They are:
Clinical research governance, funding and policy frameworks
Regulatory systems
Ethical oversight
Clinical research infrastructure
The health agency incorporated inputs from 3,000 stakeholders from across sectors in 48 countries to develop the guiding principles of an effective clinical trial stratefy. It "covers trials for any health intervention, including, but not limited to pharmaceutical medicines; vaccines; diagnostics; nutritional measures; cognitive, behavioural and psychological interventions; preventive care; digital and public health approaches; and traditional or herbal measures".
The impetus behind the document was a resolution adopted at the 75th World Health Assembly in 2022 to improve the quality and coordination in medical research.