The earliest and likely the strongest driver behind sponsors preparing for the creation of plain language summaries (PLS) is the pending regulatory requirement that would mandate these documents. Specifically, the European Union Clinical Trials Regulation (EU CTR) 536/2014 would require creating a PLS of trial results for any interventional trial with EU participants. The requirement, which will phase in with the launch of the EU clinical trials portal and database, will require new trials to provide a PLS within one year of trial completion (six months in the case of pediatric trials) and with translation of the PLS into the local language of each EU country where the trial was conducted. An English version of the PLS is also recommended, even if not required for trial participants, to facilitate use of a common language that will allow for greater accessibility.
Continue reading to learn more about the timelines and tools for a successful PLS program.