WHO - Public consultation on WHO guidance for best practices for clinical trials

27th July 2023

WHO - Public consultation on WHO guidance for best practices for clinical trials

In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. Please see action 2 under section “Requests the Director-General” at the end of WHA 75.8 resolution here. WHO is launching a public consultation on draft guidance developed in line with this request.

We aim to obtain input from all relevant stakeholders, spanning all diseases and health conditions during this consultation, so that these inputs can be taken into account in revision of this draft, following advice from the WHO Technical Advisory Group established to support this process.

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.

We would like to receive your overall comments on what the draft guidance does well and less well at the moment, as well as comments on the sections of the document and line by line if desired. Please review the request for guidance development in WHA resolution 75.8 before providing comments. Please use the online form accessible through the following link to provide inputs.

DEADLINE for the submission of comments is 15^th September 2023.  Please feel free to contact us at WHA758@who.int for additional information.

Please note we are providing a Word file of the full list of questions to help you plan your online submission – DO NOT make a submission using the word file, the submission should be through the online form. Wherever possible, please coordinate one submission per department or per institution using the word file to collate input into consolidated submissions through the online form.

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