The World Health Organization (WHO) has issued new guidance aimed at broadening diversity in clinical trials, addressing factors beyond race and gender. The guidance emphasizes the need for inclusivity of various underrepresented populations to ensure that clinical research benefits the broadest range of people possible.
Expanding Diversity in Clinical Trials
WHO's new guidelines address the underrepresentation of ethnic minorities, stigmatized populations such as LGBTQI+ individuals, and those at age extremes. The guidance also recognizes the need to include pregnant and lactating women, patients from lower socioeconomic backgrounds, and patients facing language barriers.
Dr. Jeremy Farrar, WHO’s chief scientist, stated, "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."
Data from 2022 indicates that less than 5% of clinical trials included pregnant women, and only 13% included children, which has reduced the quality of evidence and affected care and access to interventions. The absence of adequate trialing in underrepresented populations can lead to a cautious approach in treating them, negatively impacting their health.
Addressing Social Determinants of Health
Traditional clinical trial data tends to be siloed and focused only on clinical measures, without incorporating the broader social, economic, and environmental factors that can influence patient health and trial participation. Incorporating non-traditional data sources, such as social determinants of health (SDOH), into clinical trials can give researchers a more comprehensive understanding of the patient populations they are trying to recruit and retain. Insights from SDOH can help identify and address specific barriers that may be preventing underrepresented patients from participating in clinical trials, such as transportation challenges or financial constraints.
Community Engagement and Trust
Building trust within communities is essential for improving public confidence in clinical research. Thad Wolfram, president of EmVenio Research, emphasizes the importance of considering communities as a whole and addressing challenges such as food insecurity and housing instability, which can significantly impact a patient’s ability and willingness to participate in a trial.
"By combining these challenges, we can engage these communities and make it easier for them to participate in research. By doing so, we can be valuable members of these communities and contribute to their well-being," Wolfram says.
Strengthening Global Clinical Trial Infrastructure
The WHO guidance sets the stage for building robust clinical trial infrastructure, especially in low- and middle-income countries. Michael Young, co-founder of Lindus Health, notes that by developing a blueprint for conducting efficient trials domestically, biotechs all over the globe can accelerate the time-to-market for their essential medical interventions.
Regulatory bodies, including ethics committees, can only respond quickly in emergencies if they have adequate resources and capacity. Therefore, it is essential that resources are provided for training personnel in proportionate regulatory processes and research ethics in normal times.
Regulatory Alignment and Implementation Challenges
While the WHO guidance aligns with that of the FDA and EMA on different topics, some experts believe that unless this guidance is adopted by the big regulators, it is unlikely to have much impact on trial design. Dr. Oren Cohen, chief medical officer and president, clinical pharmacology at Fortrea, says that sponsors need to act on the advice to ensure that underrepresented patient populations feel represented in clinical trials.
Dr. Dominique Demolle, CEO of Cognivia, agrees that the WHO guidance aligns with that of the FDA and EMA, noting the recent draft guidance from the FDA about the Diversity Action Plan as a clear mirror of what is in the WHO recommendations.
Despite the support the WHO guidance would likely receive, largely down to its close alignment to major regulatory guidance, Demolle believes that with global studies, there could still be some issues with countries that may not have the infrastructure to run large global studies. There are also questions as to whether the FDA will accept data from patients in certain countries due to Section 569B of the Federal Food, Drug, and Cosmetic Act.
