Statistical Programming in an Era of AI

The rapid ascent of Large Language Models (LLMs) has sparked a debate regarding their role in streamlining clinical submissions, notably in the creation of SDTM, ADaM, and TLFs. Central to this is the extent to which we can depend on AI for the autonomous generation of analyses - a notion as rich in promise as it is with challenges. As the world tries to figure out the best ways of applying AI across industries, it's crucial for us to reevaluate the processes involved in delivering clinical trial submissions. Key questions underpinning this debate include:

• What tasks can genuinely be automated using AI, and which should not?
• In what aspects does human expertise remain indispensable?
• How do we guarantee validation and integrity of submissions to regulatory authorities?

As we inaugurate the first Verisian Community Event, our aim is to bring together stakeholders and foster a vibrant discussion around the future of these critical issues. Through a series of talks, we will explore both the opportunities and limitations of employing AI in statistical programming for generating SDTM, ADaM, and define-xml, among others. This event seeks to establish a collaborative environment for sharing insights, experiences, and strategies to navigate the adoption of the latest technological advancements. We invite all those interested in the future of statistical programming to join us.

Host or Publisher Verisian