WHO Published Guidance for Best Practices for Clinical Trials in September 2024

In 2022 the World Health Assembly adopted resolution WHA75.8 on strengthening clinical trials. WHO developed its guidance in response to that resolution, and the resulting document, Guidance for best practices for clinical trials, was published on 25 September 2024.

The guidance was developed over about two years with a WHO Technical Advisory Group. According to WHO, it is intended to make clinical trials more efficient, to reduce research waste, and to help trial systems function well in normal times while being able to adapt quickly during health emergencies and pandemics. WHO’s own page describes the practices as intended to improve the efficiency and equity of trials, particularly in low- and middle-income countries.

A WHO Western Pacific Regional Office article published on 15 October 2024 described the guidance as a starting point rather than an endpoint, setting a foundation for public health research that would be built on through further implementation work.

The guidance addresses the whole clinical trial ecosystem rather than a single stage of research. Summaries published by ECRIN and others identify its main themes as robust trial design and conduct, transparent registration, proportionate oversight, high-quality reporting, and strengthening of national research ecosystems and infrastructure.

It is written for multiple audiences. The WHO regional office article highlights several areas of recommendation. Trials should be aligned with national research priorities and funding. Regulators should apply risk-based, proportionate oversight to clinical trials and maintain post-marketing surveillance. Effective trials also depend on adequate physical infrastructure and trained personnel, which national systems need to develop and sustain.

Unlike ICH E6, which focuses on Good Clinical Practice for trials of medicinal products, the WHO guidance is framed more broadly around the quality and efficiency of clinical trials and the systems that support them. The two documents are complementary: the WHO guidance sets expectations for how trial ecosystems should operate, while ICH E6(R3) sets detailed GCP expectations for sponsors and investigators of medicinal product trials.

The guidance is non-binding. It does not replace national laws or regulatory requirements, but it is likely to inform how Member States, funders and regulators develop policy, particularly in countries that are building or reforming their trial oversight systems. It is relevant to commercial and non-commercial sponsors, academic investigators, ethics committees, funders and national authorities.

At the time of checking, no revised edition of the guidance had been identified in the sources reviewed for this brief. Readers should consult the WHO page for any later implementation materials, translations or updates, and should rely on the full text of the guidance rather than summaries when citing specific recommendations.

For sponsors and investigators, the guidance reinforces expectations that trials should answer questions that matter to patients and health systems, should be designed to produce reliable results, and should be registered and reported transparently. For trials in low- and middle-income settings, it supports the case for proportionate regulatory and ethics review and for investment in local capacity.

For funders and research organisations, the emphasis on national priorities, infrastructure and trained personnel provides a reference point when assessing applications or designing programmes. For medical writers and protocol authors, the themes of robust design, registration and high-quality reporting align with established reporting guidelines such as SPIRIT for protocols, which can help demonstrate that a trial meets the expectations described by WHO.

Regulatory and ethics teams in countries reforming their oversight systems may also find the guidance useful as a benchmark. Its emphasis on proportionate, risk-based review gives authorities a reference when deciding whether low-risk trials need the same level of scrutiny as first-in-human or high-risk studies. Sponsors preparing submissions in such countries can usefully cite the guidance when proposing streamlined approaches, while recognising that national requirements remain binding. Because the document is addressed to the whole ecosystem, it is also a practical tool for conversations between sponsors, funders and regulators about where delays and duplication arise and how they might be reduced.