AI meets informed consent: a new era for clinical trial communication.

Abstract

Clinical trials are fundamental to evidence-based medicine, providing patients with access to novel therapeutics and advancing scientific knowledge. However, patient comprehension of trial information remains a critical challenge, as registries like ClinicalTrials.gov often present complex medical jargon that is difficult for the general public to understand. While initiatives such as plain-language summaries and multimedia interventions have attempted to improve accessibility, scalable and personalized solutions remain elusive. This study explores the potential of Large Language Models (LLMs), specifically GPT-4, to enhance patient education regarding cancer clinical trials. By leveraging informed consent forms (ICFs) from ClinicalTrials.gov, the researchers evaluated two AI-driven approaches-direct summarization and sequential summarization-to generate patient-friendly summaries. Additionally, the study assessed the capability of LLMs to create multiple-choice question-answer pairs (MCQAs) to gauge patient understanding. Findings demonstrate that AI-generated summaries significantly improved readability, with sequential summarization yielding higher accuracy and completeness. MCQAs showed high concordance with human-annotated responses, and over 80% of surveyed participants reported enhanced understanding of the authors in-house BROADBAND trial. While LLMs hold promise in transforming patient engagement through improved accessibility of clinical trial information, concerns regarding AI hallucinations, accuracy, and ethical considerations remain. Future research should focus on refining AI-driven workflows, integrating patient feedback, and ensuring regulatory oversight. Addressing these challenges could enable LLMs to play a pivotal role in bridging gaps in clinical trial communication, ultimately improving patient comprehension and participation.