Keeping the end in mind: key considerations for creating plain language summaries

Also known as a lay summary or clinical trial results summary, a plain language summary (PLS) explains the results of a clinical trial in a way that is easy for public audiences to understand. A PLS can advance a number of goals for sponsors, including transparency, patient centricity and compliance with regulatory requirements, such as European Union Clinical Trial Regulation No. 536/2014. However, many sponsors face the challenge of developing consistency and transparency in their PLS portfolio, a task made even more challenging by timeline constraints and the manner in which a PLS differs from typical regulatory documents.

Read the whitepaper to discover:

• How to plan for the PLS with endpoint consistency and specificity
• Considerations for PLS endpoint inclusion
• How to incorporate the patient voice
• Current approaches to accommodate PLS timeline
• Methods to inform participants and the public about a PLS