Global Guidance for More Effective and Equitable Clinical Trials

Syllabus :GS2/Health 

In News 

• WHO released new guidance to improve clinical trial design, conduct, and oversight globally, targeting all income levels.

About 

• The guidance was developed based on World Health Assembly resolution WHA 75.8, with input from nearly 3,000 stakeholders across 48 countries.
• Scope :The guidance covers trials for a wide range of health interventions, including medicines, vaccines, diagnostics, preventive care, digital health, and traditional or herbal measures. 
• It aims to strengthen country-led research and development (R&D) to accelerate access to safe and effective health interventions worldwide.

Key Findings 

• Global Inequities in Clinical Trials:There is a divide between high-income countries (HICs) and low- and middle-income countries (LMICs) in trial numbers (27,133 in HICs vs. 24,791 in LMICs in 2022).
  • LMICs are often included in trials due to disease burden, but results are mainly used for approvals in HICs, leaving LMICs behind.
• Limited Representation of Vulnerable Groups:Pregnant women participated in less than 5% of trials, and only 13% of trials included children in 2022, lowering the quality of evidence and reducing access to interventions for these groups.
  • The lack of inclusion of vulnerable populations limits treatment options for them and erodes their trust in health recommendations.

Recommendations

• National Authorities: For the first time, WHO offers recommendations for health authorities, regulators, and funders to facilitate better clinical trials.
  • It addresses challenges like poor trial design, limited participant diversity, infrastructure gaps, and bureaucratic inefficiencies.
• Need for Participant Diversity:WHO emphasizes including diverse participants, particularly underrepresented groups such as pregnant women (less than 5% in trials) and children (13% in trials), to improve the quality and applicability of evidence.
• Focus on Vulnerable Groups:Special guidance for including pregnant, lactating women, and at-risk populations in trials, with safety prioritized early in the process.
  • Appropriate procedures for consent and assent, especially for children, are stressed.
• Community Engagement:WHO recommends centering patient and community engagement in trials to ensure research aligns with public needs and maintains trust.
• Strengthening National R&D Ecosystems:The guidance calls for sustainable financing to strengthen national R&D ecosystems, improve decision-making, and accelerate access to health innovations.

Source : DTE