18 Sep 2023

The Collaborative submits feedback on WHO draft clinical trials guidance

The Good Clinical Trials Collaborative has submitted feedback on the World Health Organization’s draft clinical trials best practice guidance, in response to its public consultation launched in July 2023.

We commend the guidance as a vital and welcome resource that provides widely-relevant context and applicable advice to enhance global clinical trials. It effectively outlines the universal scientific and ethical considerations for conducting high-quality trials while emphasizing the significance of context-specific implementation. Our commentary is appended below.

We appreciate the opportunity to contribute to this important consultation, and look forward to the next phase of development.

Commentary on WHO draft clinical trials best practice guidance  

The draft WHO guidance for best practices for clinical trials is an important and welcome resource that provides widely-relevant context and applicable advice on essential considerations to strengthen clinical trials globally.  

It is very effective in conveying that a lack of sufficiently reliable and relevant evidence is a major limitation to public health globally and that low-resource settings and certain populations are particularly and disproportionately impacted. 

The specific emphasis on the role and unique value of randomization in generating reliable evidence about the effects of health interventions differentiates it from other internationally recognised guidelines and directly addresses a major source of research waste i.e. inadequate design. 

Advice and emphasis on the value of effective interagency priority setting, inclusive consultation and collaboration are other important themes that add value to the discussion of key design and conduct features, and help to enhance the message that good clinical trials answer important questions relevant to the populations they are intended to benefit, with findings generalizable to those populations. 

Specifically highlighting the advantages of robust but proportionate design and conduct encourages both efficient use of available resources and recognition of the opportunity cost (in terms of reliable evidence generation and public health benefit) of excessively defensive or risk-averse practices. 

Relatedly, emphasis on feasibility and utilisation of existing resources makes this guidance more practically relevant that comparable international guidelines – helping to promote robust and effective approaches in diverse settings. This, in turn, helps to promote fair and equitable relationships and practices in trial conceptualisation, design, and delivery – and can support fair distribution of related benefits (e.g. evidence dissemination, access, investment in local infrastructure). 

By providing role- and topic-specific recommendations (Annex 2), the draft guidance provides a clear rationale and pathway for concerted role-specific action and effort from major stakeholder groups (including researchers, funders and regulatory authorities) while highlighting that multilateral collaboration and coordination is essential to success – underpinned by a clear, common understanding of key scientific and ethical considerations. 

These universal scientific and ethical standards are well-described in Section A and clearly supported by emphasis that local implementation is likely to support appropriate application that takes account of important contextual factors or regulations. This will help ensure the guidance can be a functional and impactful resource for a diverse range of communities globally. 

We recognise and value the inclusive development process of the draft guidance, both in terms of the origins of key source materials utilised (for example, from CIOMS and the Good Clinical Trials Collaborative) and consultation with a diverse Technical Advisory Group and accessible, open public comment period. 

Thank you for the opportunity to comment on the draft guidance, which we strongly support and recommend. 

The Collaborative submits feedback on WHO draft clinical trials guidance Good Clinical Trials Collaborative