The World Health Organization (WHO) has published its draft guidance for best practices for clinical trials, and is now inviting members of the public to provide their feedback and comments.

The draft guidance is a response to recommendations from the 75th World Health Assembly’s Resolution on Strengthening Clinical Trials. Designed to tackle critical challenges facing clinical trials, including minimizing research waste and improving efficiency both during and outside of emergency circumstances and pandemics, the guidance outlines three core themes: clinical trial design and conduct, best practices for strengthening the ecosystem, and addressing evidence needs in underrepresented populations.

A separate public consultation last year invited inputs on how existing resources could be incorporated into the guidance development. 

The Collaborative’s Guidance for Good Randomized Clinical Trials has been utilized as a key source in developing the draft guidance and forming the basis of “Section A: Key scientific and ethical considerations for good clinical trials”, with key themes from our Guidance also amplified and reinforced through other sections of the guidance while forming the basis of important additional commentary, guidance and calls-to-action for actors across the ecosystem.

This WHO consultation comes at the same time as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) seeking public comments on the draft Good Clinical Practice E6 (R3) guideline. The Collaborative is developing a community response to the ICH consultation.

The two consultations are important opportunities for the clinical trials community to improve guidelines that will play a fundamental role in the future of clinical trials design, conduct and regulation, and we strongly recommend active participation in both.