Overview

Why clinical trials matter

Clinical trials are a cornerstone of modern healthcare. They test whether new treatments, vaccines, and health interventions are safe and truly work. The knowledge they generate provides trusted evidence for decision-making, helping ensure that patients receive care that is both effective and safe. 

By promoting rigorous, ethical research, and fostering international collaboration, clinical trials can significantly improve global health outcomes by: 

• preventing diseases,
• saving lives,
• driving medical advancements,
• supporting socioeconomic development.

Challenges facing clinical trials 

Clinical trials are increasingly facing challenges and are sometimes unable to deliver high-quality evidence that meets the needs of a rapidly changing global health environment. 

Key challenges include: 

• Trial design and context; 
  • Ensuring that trials are well-designed and implemented in ways appropriate to their context.
• Research environment; 
  • The lack of sufficiently enabling environments for clinical researchers in some settings.
• Funding and infrastructure;
  • Difficulties in securing long-term funding for trial personnel and infrastructure.
• Inclusion and engagement; 
  • Lack of inclusion of underrepresented populations, and
  • Ensuring adequate engagement with patients and/or communities in trial design, conduct and reporting. 
• Technology integration; 
  • Obstacles to integrating digital technologies may hinder the efficiency and reach of clinical trials.
• Multinational coordination;
  • Coordinating multinational, multiregional trials is complex, and 
  • The COVID-19 pandemic has emphasized the problem of research waste and the need for rapid activation and functional trial networks.  

You can read more about clinical trials.

WHO response

In May 2022, the Seventy-fifth World Health Assembly (WHA) adopted resolution WHA75.8 on “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination”.

This resolution emphasizes the critical role of high-quality clinical trials in assessing safety and efficacy of health interventions. It calls for:

1. Strengthening global collaboration: Encourages international cooperation in research and multicountry clinical trials, particularly during public health emergencies.
2. Equity and ethics: Stresses that trials should address health needs ethically and inclusively, including deliberate focus on under-represented populations.
3. Strengthening capabilities: Advocates for enhancing global clinical trial capabilities, especially in low- and middle-income countries, to meet international standards.

The resolution underscores the need for well-designed, ethically guided, and scientifically robust clinical trials to generate actionable evidence for public health policies and interventions. It also highlights the importance of transparent data sharing, capacity building, and equitable participation in clinical trials.

The resolution requests WHO Director-General to:

• Organize transparent stakeholder consultations, including Member States, Non-Governmental Organizations (NGOs), private-sector entities, and academic institutions, to strengthen the global clinical trial ecosystem.
• Review existing guidance and develop new guidance on best practices for clinical trials, considering normal and emergency contexts.
• Provide guidance to Member States on legislation, infrastructure, and capabilities for clinical trials upon request.
• Engage with non-State actors whenever appropriate to enhance clinical trial capabilities, particularly in low- and middle-income countries, focusing on under-represented populations.

Explore the related sub-pages to discover how the WHA75.8 resolution and WHO's initiatives are shaping the future of clinical trials, addressing global challenges, and fostering collaboration to advance equitable, high-quality health research.