In May 2025, the World Health Organization (WHO) published its landmark initiative to address the lack of equity in clinical trials. The Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS) is a strategic framework outlining nine priority actions designed to enhance quality, accessibility, innovation and sustainability in clinical trials. It emphasises reform in low and middle-income country (LMIC)-led research, which has been notoriously sidelined in global research efforts. According to the WHO, 70% of clinical trials are conducted in high-income countries.
Insights derived from GlobalData’s Trials Intelligence Platform support this, as only 10% of trials have a location in the Middle East and Africa, and only 3% have a location in South and Central America (Figure 1).
Go deeper with GlobalData
Access deeper industry intelligence
Experience unmatched clarity with a single platform that combines unique data, AI, and human expertise.
The priority action plan sets out the following nine actions:
- Strengthen national governance and coordination: this revolves around strengthening national research institutions and policies to improve the quality and accessibility of trials. This is especially crucial for LMICs as clinical trials tend to be externally sponsored, which often does not prioritise local health needs. Strengthening governance is foundational to serving local needs equitably, ethically and effectively.
- Improve regulatory and ethical oversight: streamlining ethical and regulatory review/approval is essential to reducing delays in trials. A successful example of the positive impact of this can be seen in the African Vaccine Regulatory Forum (AVAREF), before which clinical trials in African countries regularly faced delays upwards of 18 months. The AVAREF model developed standard operating procedures (SOPs), so that the national regulatory authorities and ethics communities worked in harmony to avoid conflicting timelines and duplication. This meant that approval timelines were reduced by half.
- Improve trial quality and participant protection: this plan focuses on utilising SOPs to ensure ethics and safety are maintained without compromising scientific rigour. The movement towards precision and personalised medicines has included the rapid popularity of advanced therapies such as gene editing. Scandals regarding clinics administering illegal stem cell therapies have demonstrated the ethical concerns surrounding these therapies and show that vulnerable populations need to be protected from exploitation.
- Enhance community and patient engagement: the perpetual plight that clinical trials face is low accrual and retention, and involving communities in the planning and conduct of clinical trials is the logical move forward towards building public trust and rectifying this issue.
- Ensure equitable participation: not only does patient accrual need to improve, but the inclusion of underrepresented populations such as ethnic minorities, women, children and those who are pregnant needs to improve. The WHO aims to achieve this in various ways, such as mandating diversity in trial protocols, and decentralised and community-based recruitment, for example using local clinics or mobile trial units to reach participants who cannot access research centres. They also propose to remove logistical and financial barriers such as paying for childcare, transport and covering lost earnings as a result of participating in clinical trials, to make participation feasible for low-income individuals.
- Expand workforce capacity: there is a skills shortage for clinical trials, especially within LMIC, and the hope is to train professionals to create a locally based workforce to reduce reliance on external researchers.
- Integrate research with health systems: this will embed trials into clinical care settings to facilitate the collection of real-world data. This enhances the generalisability of data, increasing its ability to support timely decision-making in public health.
- Advance data transparency and sharing: mandating results and data sharing in clinical trials is a long time coming. At Clinical Trials Arena’s global Outsourcing in Clinical Trials Conference series at the beginning of 2024, Andrew Ustianowski, network director of Upcoming Northwest Regional Research Diversity Network, National Institute for Health and Care Research commented that many people responsible for improving diversity within clinical trials do not even have access to this data on a global scale, which is a sentiment and frustration echoed throughout the industry.
- Securing long-term and equitable financing: this is essential for building sustainable, inclusive research systems. The importance of this was made apparent following US withdrawal from the WHO (which will become final in January 2026). The US was its largest contributor and it is therefore expected that the move will impact the clinical trials the WHO is able to support, which predominantly affect LMIC. The future of sustaining LMIC trials relies on reducing dependency on donor-driven research.
This initiative is undoubtedly ambitious, and its success depends on multiple factors such as political will, investment and strong international partnerships. However, if successful, the landscape of clinical trials as we know it will be transformed and will enter a new paradigm that shifts beyond commercial interest to focus on public health equality.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData
