Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination

In May 2022, the seventy-fifth World Health Assembly (WHA 75.8) voted in favour of a resolution urging all countries to develop their capacity in conducting clinical trials. This resolution, proposed by Argentina, Peru, and the United Kingdom, urges governments to increase the efficiency, financing, reporting, and regulatory and ethical frameworks of clinical trials and tasks the World Health Organization (WHO) with developing a global action plan to strengthen practice in this space.

To support the implementation of resolution WHA 75.8, WHO will review existing - and develop new - guidance for Member States and non-state actors on the design and conduct of clinical trials and in strengthening the clinical trial ecosystem. The George Institute was pleased to contribute to the first round of consultations in October 2022 to inform its forthcoming guidance.

Our key recommendations for best practices to improve the global clinical trials ecosystem are to:

• Ensure adequate and timely recruitment of participants to trials to meet sample size requirements, so that studies can answer clinical questions and thus avoid waste.
• Consolidate ethics practices across regions and develop better mechanisms for rapid approval.
• Ensure participation in clinical trials from sites in rural, regional, remote, marginalised and resource-poor settings, and adequate representation of underserved populations among both trial teams and participants.
• Report on diversity in trial populations and inclusivity in recruitment as a requirement of funding bodies and peer-reviewed journals.
• Ensure that trials focus on research questions and include research methods that reflect the priorities, culture, and needs of the communities they seek to serve.
• Provide universal access to affordable and comprehensive training courses in clinical trial design and conduct.
• Ensure systematic and transparent registration and reporting of clinical trials.

The full input is accessible on the WHO webpage here, and a supplementary report has been developed with more extensive summaries of the inputs received, available here.

We congratulate the WHO on the development of its guidance and stand ready to collaborate to support the implementation of resolution WHA 75.8.