The Making of the Good Lay Summary Practice Guidance: A Multi-Stakeholder Document That Was Adopted Into Regulation

Abstract

This interview describes how the Good Lay Summary Practice guidance (GLSP) came into existence. Its development had been initiated by a group of enthusiasts who wanted to provide guidance on how to plan, write, translate, and disseminate lay summaries and on how to best involve patients into the process. The GLSP is the result of a multi-stakeholder initiative with more than 60 contributing organizations, comprising patients, patient organizations, academic research networks, small and medium enterprises, and members from big pharmaceutical companies. The initiative collaborated over more than 3 years to arrive at a final guideline that was then accepted into regulation. Major steps were the development of an organizational structure consisting of a Core Management Team and 5 Task Forces that worked on the different topics, a large global public consultation of the draft document, and an intense discussion with the regulators in Europe. Dr Ingrid Klingmann, a physician, patient advocate, and cancer survivor, was at the helm of the Roadmap Initiative during the entire time and provides her insights on the challenges and results of this long and successful process.