# AI for Plain Language & Patient-Facing Content

Pharmaceutical communication has traditionally been written by scientists for scientists. But regulatory requirements and patient advocacy are driving a transformation: patients want to understand the clinical trial results for the drugs they take, and regulators are mandating that they have access to understandable summaries.

The EU Clinical Trials Regulation (EU CTR) Requirement

Since January 2022, the EU CTR (Regulation 536/2014) requires that sponsors provide a summary of clinical trial results in language understandable to a lay person. These Plain Language Summaries (PLS) must be posted to the EU Clinical Trials Information System.

PLS requirements: - Written at an 8th-grade reading level or below - No unexplained medical jargon - Results presented in absolute numbers rather than statistical measures - Clear explanation of what the trial tested and what was found - Adverse events described in understandable terms - Available in the language(s) of the participating countries