WHO guidance aims to strengthen clinical trial ecosystem

New global guidance on best practices to improve clinical trials has been released by the World Health Organization (WHO).

Fundamentally, the document offers approaches aimed at enhancing the design, conduct and oversight of clinical trials, to strengthen country-led R&D ecosystems.

The guidance is relevant to clinical trials including pharmaceutical medicines, vaccines, behavioural and psychological interventions, preventive care, as well as digital and public health approaches and traditional or herbal measures.

What clinical trial recommendations are included?

For the first time, recommendations are offered for organisations such as national health authorities, regulators and funders on ways to enable clinical trials to generate evidence on health interventions, according to WHO. Key challenges including poor trial design and limited diversity of participants are highlighted.

One of the key aspects of the guidance is ensuring trials are patient-centric, with participant engagement being at the centre of the organisation of clinical trials. For example, ensuring research planning and delivery addresses the needs of the public, WHO noted.

The agency explained that practical considerations for setting up trials to include pregnant and lactating women is part of the new guidance. They stated that a safety assessment should be a primary priority, eg, by “reviewing comparable interventions or expediting pre-clinical studies for these groups. Appropriate procedures for consent and assent are key, particularly for children”.

Furthermore, the guidance seeks improve national R&D via “sustainable financing, to support better decision-making, accelerate access to health innovation and build more robust and effective national and global health research environments”.

“Strengthening country-led research and development and embedding clinical trials in routine clinical and public health services will ensure faster and more equitable access to safe and effective interventions,” commented Dr Jeremy Farrar, WHO’s Chief Scientist. “This new guidance aims to improve the diversity of trial participants to ensure research benefits the broadest range of people possible, decisively moving away from a one-size-fits-all approach.”