CAN <i>L</i> ead: <u>Can</u> ada as a Phase 1 Clinical Trial <u>Lead</u> er — Opportunities, Initiatives, and Collaborative Innovation to Elevate National Competitiveness

Abstract Background Phase 1 oncology clinical trial have become increasingly complex, resource-intensive, but essential to modernize drug development. Despite strong academic infrastructure, Canada remains underrepresented in early-phase cancer trials relative to international peers. Methods To advance this vision, this perspective summarizes barriers and opportunities impacting the conduct of phase 1 oncology clinical trials in Canada, based on discussions from sponsor, patient advocate, ethics, and clinical research site representatives across national major phase 1 units at the inaugural “Practical Workshop of Conducting Phase 1 Trials in Canada”. Results Current challenges include overly restrictive and complex trial design that increases participant burden, study activation delays, operational inefficiencies, and limited access to investigational therapies following disease progression. However, Canada’s integrated academic cancer centers, publicly funded healthcare system, and ongoing advances in harmonization strategies present opportunities to strengthen national competitiveness in global site selection. Conclusion Participant-centric strategies, earlier collaboration amongst stakeholders, and targeted operational improvements at local, provincial, and national levels are crucial to elevate Canada as a global leader (CANLead) in phase 1 oncology clinical research. Together, these approaches position Canada to advance its competitiveness and take a more prominent role on the international stage, while also providing a practical framework for developing and optimizing phase 1 units globally.