|
Publieke consultatie gestart voor WHO guidance for best practices for clinical trials
De World Health Organization (WHO) heeft op 19 juli 2023 de concept versie van de WHO guidance for best practices for clinical trials gepubliceerd. De deadline voor het aanleveren van commentaar op het guidance document is 15 september 2023.
"Aims of this guidance - This guidance updates and adapts WHO’s previous work on research capacity for the context of clinical trials as framed in resolution WHA75.8 (2022). It aims to address the issues outlined above, improve efficiency and minimize research waste, both in normal times and in time of emergency or pandemics.
These themes are described in three sections as follows:
• Section A provides high-level guidance for clinical trial design and conduct on the key scientific and ethical features that should be universal to all clinical trials in order to enable them to produce reliably-informative, high-quality evidence relevant for informing national and international guidelines and decision-making, regardless of context;
• Section B provides high-level guidance and recommendations on best practices for the strengthening of the ecosystem for clinical trials, including enabling actions;
• Section C provides high-level guidance on how clinical trials can better address evidence needs in under-represented subpopulations, in particular, pregnant and lactating women and infants and children.
These sections are followed by a presentation of recommendations for Member States, research funders and researchers."
bron: p.11, draft WHO guidance for best practices for 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. There may also be some relevance to medical journals."
bron: WHO nieuwsbericht d.d. 19 juli 2023 |
