WHO Guidance for best practice for clinical trials

This guidance is useful for clinical trials because it provides an internationally agreed reference for ethical, scientific and methodological integrity that can be applied across different diseases, populations and settings. It can also be used to strengthen capacity by informing institutional policies, standard operating procedures and training programmes for those who design, run, oversee and report clinical trials.

• Developed in response to World Health Assembly resolution WHA75.8 (2022), which requested the World Health Organization to review existing guidance and propose best practices to improve research quality, coordination and evidence generation.
• Sets out principles and practical recommendations to enhance clinical research efficiency, reduce research waste and support clinical trial systems that function during routine conditions and can rapidly respond to health emergencies and pandemics.
• Describes key themes such as robust trial design and conduct, transparent registration, proportionate oversight, high‑quality reporting and strengthening national research ecosystems and infrastructure.