Event highlights
5 June 2024
Strengthening clinical trial ecosystems in the Western Pacific
Following the first WHO Global Clinical Trials Forum in 2023, participants have been advocating for higher quality clinical trials that can provide important insights into effective health interventions. To cross-pollinate on initiatives/ best practices in the Region and identify priority actions, the Expert Consultation on Implementing World Health Assembly Resolution WHA75.8 on Strengthening Clinical Trials in the Western Pacific was held in Selangor, Malaysia from 21 to 22 March 2024. The two-day event gathered 24 participants from 11 countries, with diverse backgrounds including research, ethics, clinical practice, funding, policy advice and regulations.
The objectives of the consultation were:
- to provide an overview of the global implementation efforts of World Health Assembly resolution WHA75.8 on strengthening clinical trials to provide high-quality evidence on health interventions and improve research quality and coordination;
- to facilitate sharing of initiatives/best practices in the Western Pacific Region that are aligned with the resolution; and
- to identify priority actions to further implement the resolution in the Western Pacific Region.
A call for more equitable clinical trials
A central theme that emerged from the consultation is “putting equity at the centre of developing and conducting clinical trials”. The discussions underscored the importance of multi-country clinical trials designed to also contribute to local public health priorities and strengthen local health systems. Recognizing the varying levels of clinical trial development within the Region, participants reiterated that international collaboration must consider the equitable involvement of countries and areas, with meaningful partnerships moving beyond the limited data collection roles for investigators in less resourced settings. With that, participants highlighted that multi-country clinical trials should also consider equitable participation opportunities of under-represented groups as well as the protection of participants’ rights amidst varying cultural norms, literacy levels and awareness of research ethics.
Another issue that attracted significant discussions was the need to build research capacity to strengthen clinical trials and its translation towards informing decision-making. While training in clinical trial protocol is integral to design and implement high quality clinical trials, additional efforts to strengthen the overall research environment and general research capacities was emphasized as a fundamental building block, especially in low resource settings. Participants also discussed the use of registries as a means to strengthen data governance and to promote research integrity through the provision of more timely and transparent data.
The way forward: a systems approach to strengthening clinical trials
Among the cross-cutting challenges discussed, the need to strengthen clinical trials at both the domestic and regional levels underpin the recommendation for a multi-layered approach to strengthen clinical trials. Embedding clinical trials into health systems was advocated as a key step to pragmatically advance the reach of clinical trials. This intent would need to be supported with an adequate healthcare workforce, through incentivizing a cadre of personnel necessary to lead and conduct clinical trials.
Finally, the meeting concluded with a commitment to support countries and areas in implementing WHA75.8 to promote equitable clinical trial capacity development and improve population health outcomes. This will involve:
- WHO engaging with stakeholders to identify entry points and a range of pathways for countries and areas to meaningfully participate in strengthening clinical trials in the Region.
- Increasing WHO’s capacity to identify and amplify good practices through case studies of well-designed and equitable clinical trials and facilitate regular knowledge exchange across the Region.
- Identifying common needs across countries and areas, while prioritizing building/ strengthening research capacity accordingly.
Event notice
The COVID-19 pandemic has created an unprecedented demand for timely, reliable and actionable data and scientific evidence. The World Health Organization (WHO) Thirteenth General Programme of Work 2019−2023 (GPW13) considers harnessing the power of science and research as a critical enabler in achieving its Triple Billion targets and the health-related Sustainable Development Goals. Well-designed and well-implemented clinical trials are indispensable for assessing the safety and efficacy of newly developed health interventions.
The Seventy-fifth World Health Assembly in May 2022 adopted resolution WHA75.8 on strengthening clinical trials to provide high-quality evidence on health interventions and improve research quality and coordination. It acknowledged the importance of strengthening global, regional and national clinical trial ecosystems to advance equitable clinical trial capacity development, improve health outcomes related to endemic diseases at the national and regional levels, and provide functional capacities that can pivot in times of emergency.
After the adoption of resolution WHA75.8, WHO developed a draft guidance for best practices for clinical trials and organized a Global Clinical Trials Forum (Part 1) in November 2023 with the aim of agreeing on a global vision for sustainable clinical research infrastructure and capacity. Part 2 of the Forum will be convened in June 2024 to work out details on the identified solutions.
In accordance, WHO regional offices have been tasked to facilitate regional expert consultations and provide input for the planned WHO Global Clinical Trials Forum (Part 2) to take place in 2024. An expert consultation on strengthening clinical trials in the Western Pacific will be held from 21 to 22 March 2024 at the National Institutes of Health in Malaysia.
The objectives of the consultation are:
- to provide an overview of the global implementation efforts of World Health Assembly resolution WHA75.8 on strengthening clinical trials to provide high-quality evidence on health interventions and improve research quality and coordination;
- to facilitate sharing of initiatives/best practices in the Region that are aligned with the resolution; and
- to identify priority actions to further implement the resolution in the Western Pacific Region.