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WHO’s Suggestion on Scientifically Sound and Equitable Clinical Trials
Context:
The World Health Organisation (WHO) has emphasised the need for better-designed clinical trials that are scientifically sound and equitable, particularly in the context of global disparities in health research. A new guiding document aims to address these challenges by enhancing the quality and inclusivity of clinical trials across various population groups.
Key Points:
Current Disparities in Clinical Trials:
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- A significant divide exists between high-income countries (HICs) and low- and middle-income countries (LMICs) regarding the quantity and quality of clinical trials.
- In 2022, 27,133 trials occurred in 86 HICs, while 24,791 were conducted in 131 LMICs.
- LMICs are often included in trials due to disease burdens, but resulting data may not benefit these populations.
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Lack of Representation in Trials:
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- Vulnerable populations, such as pregnant women (less than 5% participation) and children (13% participation), are underrepresented.
- This lack of diversity lowers the quality of evidence and affects healthcare access for these groups.
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Guiding Principles for Effective Trials:
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- The WHO document aims to assist national health authorities and stakeholders in overcoming challenges like poor design, limited diversity, and bureaucratic inefficiencies.
- Recommendations include engaging patients and communities in all phases of clinical trials to meet public needs and build trust.
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Focus on Sustainable Financing:
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- Prioritising sustainable financing is essential for strengthening research ecosystems in various countries.
- This support will facilitate faster access to health innovations.
Scientific Rigour in Trials:
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- WHO stresses the importance of using randomisation and blinding to minimise bias and enhance outcome reliability.
- Selecting diverse and adequately sized trial populations is crucial, including pregnant and lactating women and paediatric groups.
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Four Pillars of Clinical Trial Ecosystem
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- Clinical Research Governance, Funding, and Policy Frameworks
- Regulatory Systems
- Ethical Oversight
- Clinical Research Infrastructure
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Inclusive Development Process
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- Inputs from 3,000 stakeholders across 48 countries were incorporated to shape the guiding principles.
- The recommendations apply to all health interventions, including pharmaceuticals, vaccines, diagnostics, and public health approaches.
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Conclusion
The WHO’s guiding document aims to enhance the scientific robustness and equity of clinical trials worldwide, ensuring that research meets the needs of diverse populations. By implementing these recommendations, stakeholders can foster a more inclusive and effective clinical research environment that ultimately improves health outcomes globally.