Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results

The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to be finalised EU database. In this article, we review the proposed content of the layperson summary and identify issues related to the writing of such documents.