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Writing Lay Language Summaries of Study Results according to EU Regulation

Medical Communication
Workshop profile:
This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation (536/2014). Participants should understand the structure of clinical study reports (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics). Previous experience in writing documents (such as Informed Consent Forms) for study participants or the public is helpful.
Writing lay summaries is difficult and challenging. Medical writers need to know and apply plain language writing principles. However, the provision of lay summaries comprises many other activities and skills. The workshop will introduce the many different aspects of providing lay summaries: knowledge on the available regulatory guidance, the positions of the various stake holders (pharma and patient organisations), the challenges of the actual writing of lay summaries, and the necessary considerations for appropriate translation and distribution of the lay summaries.
The workshop will introduce the requirements for lay language summaries of study results according to the EU regulation. The various guidance documents from stakeholders (TransCelerate, MRCT, European Expert Group, Good Lay Summary Practice Initiative [EudraLex 10]) will be introduced and briefly discussed. The content requirements for lay summaries will be presented and possible approaches will be discussed. However, only the basic principles of plain language writing will be covered. Participants will be asked to write a short paragraph of a lay summary based on a clinical document. In addition, methods for patient involvement in writing and review of lay summaries will be highlighted. Furthermore, translation of lay summaries and the various distribution options will be presented and discussed.