Strengthening sustainable clinical trial models for greater health impact: Expert discussion from the Annual Wellcome Major International Programme Regional Meeting 2024.

Background Despite growing clinical trial activity in low- and middle- income countries (LMICs), global research inequities persist, with industry funding often prioritizing high-income markets over LMIC health needs. Academic clinical trial units (CTUs) in LMICs play a critical role in delivering locally relevant research, building capacity, and supporting sustainable trial ecosystems. This manuscript reports findings from the 2024 Wellcome Major International Programmes (MIPs) Regional Annual Meeting on sustainable clinical trial models in LMICs. Methods The meeting was held from 16–18 October 2024 at the Oxford University Clinical Research Unit in Vietnam and included representatives from research institutions across Africa, Asia, and the United Kingdom (UK). A dedicated workshop explored collaborative research networks, innovative trial designs, emerging technologies, and sustainable funding models. Presentations, breakout discussions, and plenary reflections were recorded, transcribed, and analysed thematically. Results Participants identified common challenges including limited clinical trial literacy, unstable funding, workforce recruitment and retention difficulties, inequitable research partnerships, regulatory and ethics bottlenecks, operational inefficiencies, and barriers to conducting trials in remote settings. Proposed solutions included locally led research agendas, diversified funding mechanisms, stronger engagement with regulators and communities, and investment in workforce development. Participants also advocated for more efficient trial designs, including adaptive and platform trials, decentralized research models, shared monitoring systems, and interoperable electronic data platforms. A major outcome of the meeting was an agreement to explore the establishment a formal collaborative alliance between MIPs to support shared infrastructure, training, advocacy, and cross-site trial delivery. Conclusions LMIC-based CTUs are well positioned to lead more equitable, context-responsive, and sustainable clinical trial ecosystems. Strengthening collaboration through formalized regional networks may enhance trial capacity, improve efficiency, and support greater regional self-reliance in clinical research.