The FDA is working with sponsors and stakeholders on a pilot program intended to accelerate first-in-human trials, with Amgen and Memorial Sloan Kettering cited among key participants. The effort is framed around shortening early-phase timelines as companies seek faster pathways into patient studies. At the same time, the Society for Clinical Research Sites (SCRS) warned that clinical trial sites face an AI governance gap: sponsors push AI tools onto sites while also using AI to score and rank site performance without transparency or recourse. SCRS called for clearer guidelines on inputs, logic, and accountability when algorithms drive selection decisions. Together, the developments reflect how trial operations are becoming more data- and algorithm-dependent—raising both execution speed and compliance transparency as immediate priorities for sponsors and CROs.