Presentation (CTI)

OBJECTIVES: The German AMNOG/G-BA benefit assessment process demands rigorous, evidence-based dossiers synthesizing complex clinical, methodological, and economic information. Specialized AI tools are fundamentally reshaping medical writing workflows. This work aims to characterize how AI-assisted document development enables medical writers to transition from content creators to strategic medical editors who guide, curate, and refine AI-generated outputs while focusing on argumentation strategy, regulatory alignment, and critical appraisal.
METHODS: Insights were derived from two complementary sources. A structured workshop with experienced HTA medical writers—with over a year of comprehensive Regulaido use, an AI tool specifically developed for HTA and regulatory medical writing, and involvement in its development—explored role transformation through four independent working groups addressing: (1) the transition from manual executor to strategist/editor; (2) AI's role in this transformation; and (3) ensuring of result quality. Group outcomes were consolidated to derive consensus. A structured survey quantified professional perspectives on AI-enabled role evolution.
RESULTS: Expert groups converged on key findings. Role evolution requires a fundamental mindset shift supported by robust onboarding and iterative AI tool adjustments. AI functions as a "teammate" executing operational tasks—processing large clinical datasets, data extraction and transfer, rapid draft generation, cross-document comparison, and translation—while medical editors assume strategic oversight and final accountability. Key requirements for success include: ensuring the tool has full context and understands human-defined strategic goals; onboarding focused on content and process knowledge; and AI-human verification replacing traditional four-eye review. Crucially, clinical expertise, critical appraisal, and ethical judgment of trained professionals remain irreplaceable, with human-in-the-loop review guaranteeing scientific integrity.
CONCLUSIONS: AI does not replace the medical writer—it elevates the role. By taking over repetitive, time-consuming tasks, AI enables HTA professionals to become medical editors: strategic leaders ensuring scientific rigor, regulatory compliance, and compelling benefit-risk narratives, with implications for cross-functional collaboration, training, and the future of regulatory medical writing.