SC04: AI-Generated R Code in Combination with Simulation Software for Clinical Trial Design: A Case Study Approach

Over the past decade, R coding has quickly become the language of choice in the biostatistics field. Coding in R allows for almost limitless flexibility in implementing novel tests, methods, and analyses as part of a design project. However, with this high degree of flexibility are drawbacks. Coding in R requires advanced programming training in addition to trial design methodology. Additionally, realizing the full potential of R coding for clinical trial simulation requires a large computing grid for execution. Finally, results derived from R-coded projects can be difficult to analyze and communicate and often attract additional scrutiny from regulators. Conversely, commercial statistical design software offers dependable and reproducible design workflows, reliable implementation of methodology, and shareable file formats and visualizations for select design and analysis types. This course will outline a third, hybrid option combining the power of AI-generated code alongside statistical software for a new approach to trial design. East Horizon – Explore is Cytel's most advanced simulation-driven software application for adaptive clinical trial design. The software leverages immense cloud computing and R code integration points that offer flexibility in design and analysis to optimize and fine-tune adaptive designs with unparalleled precision and confidence. Among the tools embedded within the software is a large language model (LLM)-powered, AI-driven coding assistant that allows for software-compatible code creation using natural language prompts. The workshop will survey the implementation of novel tests and analyses within software workflows and include demonstrations of design and analysis of several study types. The intended audience is trained biostatisticians and programmers working in the clinical trial design field . Workshop participants will receive 14-day access to the East Horizon platform as part of the training. Limited-time access will give participants first-hand experience with the full functionalities of East Horizon, including tools covered in the workshop and additional features for extended learning and practical application. A certificate of participation will be provided to workshop attendees.