Systematic reviews are needed to address gaps in population representation in clinical trials to ensure the quality level of evidence rises, according to a senior adviser at the World Health Organization (WHO).
Vasee Moorthy, senior adviser in WHO’s science division, was speaking at the Outsourcing in Clinical Trials and Clinical Trial Supply East Asia held in Seoul, South Korea, from 3 to 4 December.
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“We often see that the populations that are most in need of interventions are not included in clinical trials,” Moorthy said.
Underrepresented populations are one of the key areas being addressed in the WHO’s new guidance for best practices for clinical trials. The agency has laid out sweeping changes that should be implemented to ensure safe and effective clinical trials. The document makes recommendations to sponsors, clinical research organisations (CROs), investigators, and regulatory agencies as WHO aims to improve the design, conduct, and oversight of clinical trials in countries of all income levels.
Less than 5% of clinical trials included pregnant women, as per 2022 data compiled by WHO. The same analysis also shows that only 13% included children. WHO stated in September that this has “lowered the quality of evidence, affecting care and access to interventions.” The thalidomide tragedy in the 1950s and 1960s set back evidence-based clinical research and medicine for women who are pregnant or may become pregnant. Whilst female participation in clinical trials is slowly improving, pregnant women still lag in trial representation.
“There is a disconnect between the populations in trials and the populations that interventions seek to benefit, including older people, pregnant women, and children,” Moorthy said.
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By GlobalDataThe lack, and in some trials complete absence, of testing medicines in underrepresented populations can lead to a cautious approach to treatment. This, as Moorthy explains, can often lead to those who are at higher risk of a disease missing out on a therapy due to not being included in the licensed indications.
This arose a few months ago when Australian mothers and babies were at risk due to a critical shortage of several crucial medicines considered safe for use in pregnancy. There are only six drugs registered to treat high blood pressure in pregnancy in the country. Analysis by GlobalData demonstrates that 4% of clinical trials globally initiated in 2024 include pregnant women in their inclusion criteria compared to 36% that have the population group in their exclusion criteria.
“There needs to be a systematic process to look at why certain populations are excluded [from trials], or why to include them later in the trial,” Moorthy said.
There are green shoots already, with Bavarian Nordic set to evaluate its mpox vaccine in pregnant women in a Phase III trial. Pregnant women are one of the groups being adversely affected by the ongoing mpox outbreak in Africa, and their access to the vaccine is currently limited.
