Reimagining Clinical and Regulatory Medical Writing With Generative AI

Abstract

The emergence of groundbreaking clinical targets and treatment modalities is fueling a surge in the number of clinical trials. This increased volume, coupled with the growing complexity of trials, is putting immense pressure on medicine’s development process. One immediate area of opportunity for streamlining clinical trials is clinical and regulatory medical writing. Generative AI (GenAI) has the potential to revolutionize medical writing by automating routine tasks, improving consistency and quality, and enabling faster turnaround times. This frees medical writers from mundane work, allowing them to focus on strategic initiatives and exert greater influence within life sciences organizations. This article explores the current state of clinical and regulatory medical writing, the challenges posed by the increasing complexity of clinical trials, and how GenAI can be used to address these challenges. The article also discusses the ethical considerations of using GenAI in medical writing and the importance of human oversight and review. Overall, the article builds a compelling case for the use of GenAI in medical writing and outlines a roadmap for the future of this field.