By Elizabeth Chimobi
The World Health Organization (WHO) yesterday introduced a new set of global recommendations aimed at improving the effectiveness and equity of clinical trials across countries of all income levels.
The guidance focuses on enhancing national research and development (R&D) ecosystems to better support the development of health interventions, ensuring they are accessible and affordable globally in a more timely manner.
By addressing both the design and operational challenges in clinical trials, this guidance intends to reduce the inefficiencies that cost time, money, and lives.
A critical issue raised by WHO is the disparity in clinical trial activity between high-income countries (HICs) and low- and middle-income countries (LMICs).
In 2022, 86 HICs conducted 27,133 clinical trials, while 131 LMICs hosted 24,791 trials. Despite the significant disease burdens in LMICs, the data generated from clinical trials conducted there is often used to obtain approval for health interventions in HICs, but not in the LMICs themselves. This creates a gap in access to new interventions, perpetuating global health inequities.
WHO’s Chief Scientist, Dr. Jeremy Farrar emphasized the importance of integrating clinical trials into routine healthcare services to ensure that more populations have access to safe and effective health interventions.
Farrar also highlighted the need for greater diversity in trial participants, stating that current research approaches are too narrow, often excluding vulnerable groups, such as pregnant women and children, which hinders the overall quality of evidence produced.
Data from 2022 reveals that fewer than 5% of clinical trials involved pregnant women, and only 13% included children.
This underrepresentation poses risks for these groups, as healthcare providers may be cautious in applying untested treatments to them, leading to suboptimal care. It also contributes to mistrust in health recommendations among underrepresented populations.
The new guidance encourages the inclusion of these vulnerable groups from the earliest stages of clinical trials.
Practical suggestions include assessing the safety of interventions for these populations through preclinical studies and ensuring proper consent and assent procedures for groups like children.
The goal is to better address the unique healthcare needs of pregnant and lactating women and other at-risk populations.
Another central theme in the guidance is the need for active patient and community engagement throughout the trial process. By involving participants and communities in the planning, execution, and dissemination of research, the recommendations aim to ensure that clinical trials are aligned with public needs and maintain public trust in health interventions.
To sustain improvements in clinical trial design and operations, the WHO calls for stronger national R&D ecosystems, supported by sustainable financing mechanisms. This would accelerate decision-making, foster innovation, and create a more robust global health research infrastructure.
The guidance was developed in response to World Health Assembly resolution WHA 75.8, through a collaborative process involving nearly 3,000 stakeholders from 48 countries.
It covers a broad range of health interventions, including pharmaceuticals, vaccines, diagnostics, behavioral therapies, public health approaches, and traditional or herbal measures.
By addressing these diverse areas, WHO’s recommendations seek to foster a more inclusive and effective global health research landscape.