Plain Language Summaries A Necessity For Global Transparency

Explore the expanding role of Plain Language Summaries (PLS) as a cornerstone of global clinical trial transparency and patient engagement. As regulatory authorities and industry stakeholders increasingly prioritize accessible communication, PLS are becoming not only a best practice but, in many regions, an emerging requirement.

This session will examine both protocol summaries and clinical trial results summaries, highlighting their distinct objectives, audiences, and compliance considerations. Attendees will gain insight into the evolving regulatory landscape across key markets, including current guidance, implementation timelines, and regional nuances that influence global strategy.

In addition, the discussion will outline practical best practices for developing, localizing, and disseminating PLS at scale — from governance frameworks and cross-functional collaboration to readability standards, health literacy principles, and digital distribution channels. By the end of the session, participants will be equipped with actionable strategies to design and operationalize a sustainable, globally aligned PLS program that supports transparency, regulatory compliance, and meaningful patient engagement.