Lay Summaries of Clinical Trial Results

Rubrik: europharm

(Treffer aus pharmind, Nr. 09, Seite 835 (2023))

Schütz R | Ditz S

Lay Summaries of Clinical Trial Results / Schütz and Ditz • Lay Summaries of Clinical Trial Results · Schütz R, Ditz S · GKM Gesellschaft für Therapieforschung mbH, Munich (Germany)
Lay summaries are the “plain language equivalent” to the scientific summaries of clinical trial results intended for laypersons without any knowledge of clinical trials or medical concepts. Providing a lay summary for clinical trials is for the first time a mandatory requirement by the European Union Clinical Trials Regulation (EU CTR) 536/2014 that came into force by end of Jan. 2022 [ 1 ]. This requirement applies to all interventional and minimal-interventional clinical trials – irrespective of the clinical trial phase and outcomes. However, for non-interventional studies or medical device trials it does not apply [ 2 ]. The aim of a lay summary is to ...