European Commission Details How Sponsors Should Prepare Lay Summaries

The European Commission has published documentation outlining how to prepare, write, translate and disseminate lay summaries of clinical trial results, which are required by EU regulations in order to improve transparency.

The 85-page guidance consists of two sections: a quick guide of essentials as well as a full Good Lay Summary Practice handbook that goes into greater detail.

Sponsors should start planning their lay summary during protocol development in order to budget, secure resources, establish timelines, develop a lay summary template and obtain patient input, as well as to decide how the summary will be widely disseminated, the guidance notes.