Clinical trials and evaluation of AI tools in solid organ transplantation: implications for clinical care, regulatory science, and rare diseases

Artificial Intelligence (AI) has widespread applications in solid organ transplantation (SOT), a field that fundamentally depends on optimizing complex paradigms across the continuum of care-from organ allocation to post-transplant management. However, only a minority have been tested through clinical trials. This perspective aims to synthesize the literature, identify gaps, and future directions for clinical trials of AI tools in SOT and how they may inform applications in related contexts.