Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance

Abstract

To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no regulatory guidance has been produced. The main goal of this article is to raise awareness of other resources that writers can use in the interim. This includes templates, guidance, and examples published by the Harvard Workgroup and the Center for Information and Study on Clinical Research Participation, whose work is supported by the EMA and FDA.

Keywords:

• Disclosure
• Layperson summary
• The Harvard Workgroup
• The Center for Information and Study on Clinical Research Participation

Additional information

Notes on contributors

Claire L. Gillow

Claire L. Gillow, MB ChB, has 9 years' experience as a medical writer including stints in early phase, late phase, and independent imaging. Prior to this she worked as a doctor in Glasgow and as an English language consultant for numerous companies in Spain and Germany. She is currently completing a Masters in Regulatory Affairs run by TOPRA, and is writing her dissertation on CT transparency.