Clinical Trial Regulation Conference

With the start of CTIS, the European Clinical Trial Regulation (EU-CTR) comes to life. For the first time in regulatory history, the EU-CTR requires that sponsors develop easy to understand summaries of clinical trial results irrespective of indication, clinical phase and whether or not a trial was successful. As there is limited instruction in the regulation, several international working groups have developed guidance documents to help both academia and pharma to write and distribute lay summaries appropriately.

The session will shortly summarize the legal requirements and the available guidance documents for lay summaries. Working groups on European level (European Expert Group), and on international level (TransCelerate, MRCT) have contributed to a clearer understanding of the issues and possible solutions. The Good Lay Summary Practice Handbook (GLSP ), which is the most recent result of cross-regional and cross-industry alignment, will be introduced during the session. Furthermore, the remaining “hot topics” in the realm of lay summaries will be presented and discussed.