WHO publishes "Guidelines for Best Practices in Clinical Trials
The World Health Organization (WHO) has recently published the Global action plan for clinical trial ecosystem strengthening (GAP-CTS), aiming to support countries in strengthening their national clinical research ecosystems. The document provides practical recommendations to make clinical trials more efficient, ethical, inclusive, and focused on public health priorities.
This new guide comes in response to Resolution WHA75.8, adopted by the World Health Assembly in 2022, which emphasized the need to improve the quality, coordination, and oversight of clinical trials globally.
Among the main highlights of the document, the WHO emphasizes:
- The centrality of involving patients, participants, and communities in the planning and implementation phases of trials;
- The need to facilitate the inclusion of under-represented populations, such as children, pregnant women, and the elderly;
- The proposal for supervision proportional to the scientific and ethical risk of trials, replacing uniform approaches with more tailored models;
- The importance of investing national resources to build robust, coordinated, and sustainable clinical research ecosystems.
The guidelines also call for meeting previously established targets by the WHO and the World Health Assembly, such as the minimum investment of 2% of national health budgets in science and R&D, and 5% of health-related development assistance in research.
According to WHO, countries that prioritize strengthening clinical trials could benefit from:
✔ Greater public trust in health research;
✔ Higher-quality local scientific evidence for clinical and public health decisions;
✔ Faster and more equitable access to innovation;
✔ Increased resilience in health crisis situations;
✔ Healthier populations and more dynamic economies.
WHO reaffirms its commitment to supporting countries in implementing these recommendations, contributing to fairer and more effective access to health interventions globally.