Abstract
This manuscript critically examines the challenges associated with the design and conduct of academic global breast cancer trials outside the influence of pharmaceutical companies, leveraging insights from the Breast International Group (BIG). In the past 4 decades significant declines in breast cancer mortality have occurred, partly related to industry-academic clinical and translational partnerships with long term study follow up. However, in the past decade these partnerships have largely uncoupled. The increasing complexity and non-alignment of trials, funding constraints, regulatory complexity, declining academic freedom, lack of transparency, and lack of affordability of new agents have become key barriers to equitably improving cancer outcomes. Industry research expenditure in the United States is now 5 fold greater than publically funded academic research. To address these challenges, we advocate for patient centred systemic reforms, with trials balancing commercial interests with public health imperatives. These reforms should include equitable research funding models, streamlined international clinical trial regulatory processes, and increased collaboration across diverse stakeholders. Practical solutions to enhance global trial accessibility and efficacy include leveraging digital technologies, artificial intelligence, real world data, decentralizing clinical trial infrastructure, and embedding translational research frameworks across countries.