In September 2024, the World Health Organization (WHO) launched its landmark publication "Guidance for best practices for clinical trials". This pivotal document is described as "not an endpoint but a starting point" (1) for enhancing global health through robust, ethical, and inclusive clinical research. It serves as a foundational resource aimed at improving the design, conduct, and oversight of clinical trials worldwide, while fostering collaboration and equity in research.
Key considerations
The WHO's guidance introduces essential scientific and ethical considerations for trial design. It also outlines a comprehensive framework anchored in key pillars designed to reinforce the global clinical trial ecosystem, emphasizing inclusivity, ethics, and transparency. The four key pillars for the ecosystem are:
- Clinical research governance, funding and policy frameworks: clinical trials should align with national and regional research priorities, with coordinated funding and evidence synthesis that translates into public health benefits.
- Regulatory systems: regulatory authorities should have oversight for medicinal products including post-marketing surveillance and support of clinical trials using risk-based proportionate approaches.
- Ethical oversight: ethical considerations permeate all aspects of health, hence, interagency coordination, and harmonization is vital to reduce duplication and ensure a rigorous and prompt authorization process.
- Clinical research infrastructure: adequate physical infrastructure and trial personnel are essential for efficient high-quality clinical trials.
Support for implementation in the Western Pacific Region
This document was developed under the guidance of the WHO Technical Advisory Group (TAG) on Best Practices for Clinical Trials, through global and regional consultations, alongside opportunities for public consultation. The expert consultation on implementing World Health Assembly Resolution WHA75.8 on strengthening clinical trials in the Western Pacific provided additional input for the draft guidance on strengthening the clinical trial ecosystem. For the Region, participants of the consultation identified priorities underscoring principles of equity in building local research ecosystems, and systematic approaches to improve data governance and promote research integrity, as elaborated in The Selangor Consensus: strengthening clinical trials for local public health in the Western Pacific.
The WHO Regional Office for the Western Pacific is committed to provide support to Member States that wish to apply this best practice guidance to reform, improve and streamline their clinical trial ecosystems. By adopting this guidance, Member States are poised to gain major benefits such as better locally derived evidence and more equitable access to innovation and medical products, thereby leading to improved health outcomes.
(1) Jeremy Farrar, Chief Scientist, World Health Organization - Launch webinar, 25 September 2024