WHO has started conducting public consultation on WHO draft guidance for best practices for clinical trials. The guidance aims to provide support to Member States and non-State actors in strengthening clinical trial capabilities, infrastructures and ecosystems. This guidance is developed in response to the WHA75.8 resolution on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. It emphasizes the people-centered approach with a particular focus on addressing the needs of under-represented populations, such as children, pregnant and lactating women and older adults in clinical trials.
Important stakeholder groups for this technical guidance include, (but are not restricted to): public sector researchers, private sector entities engaged in clinical trials, national health authorities or research councils involved in health research, clinical trial registries, research ethics bodies, national or transnational medicinal product regulatory authorities, decision-making bodies making use of evidence such as guidelines developers, and health technology assessment bodies, healthcare practitioners, patient engagement and community engagement entities, and professional associations in disciplines for whom clinical trials of health interventions are relevant.
The public consultation will be followed by a series of country, regional, and global consultations and specific stakeholder engagement activities towards the successful implementation of the resolution.
DEADLINE for the submission of comments is 15th September 2023. Please feel free to contact WHO at WHA758@who.int for additional information.