浅谈简明语言摘要

This guidance was developed in cooperation with the Roadmap Initiative to Good LaySummary Practice and adopted by the Clinical Trials Expert Group (CTEG, a working group ofthe European Commission representing Ethics Committees and National CompetentAuthorities (NCA)). Version 1 Good Lay Summary Practice This “Good Lay Summary Practice” (“GLSP”) provides recommendations on how to prepare, write,translate, and disseminate summaries of clinical trial results in lay language. This is a mandatoryrequirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of16 April 2014 on clinical trials on medicinal products for human use1(“EU CTR”) and a transparencyobligation to all trial participants and the interested public. How to Use This Document The GLSP is organised in two parts. Part 1 is a GLSP Quick Guide and Part 2 is the full GLSP Handbook.The GLSP Quick Guide contains core extracts from the GLSP Handbook and may serve as an overview ofthe recommendations offered in the Handbook. Since the intention of the GLSP is to provide practicalrecommendations and strive for good lay summary practices, professionals directly involved in laysummary projects are encouraged to read the full handbook to benefit from the detailedrecommendations. The GLSP recommends clinical trial sponsors to organise the lay summary process (“LS process”) in foursteps: planning, development, translation, and dissemination. A stepwise approach will help sponsorswith their proactive planning and execution and will ensure a high quality of the lay summary (“LS”).However, unless otherwise stated, the order in which information is presented in the GLSP does notnecessarily drive a linear process with a set order of priorities. Company or research institutionalstandard operating procedures (SOPs) and other considerations may require activities to be performedin another sequence. The four steps and related core activities are depicted in the flowchart below with further defined inputand output. It is recommended that the trial sponsor determines which output or deliverables may bedesired before a next step is initiated. For easy navigation, both the Quick Guide and the Handbook areorganized in the same way. Throughout the GLSP, the use of the word “must” refers to legal requirements, as laid out in the EU CTR,whereas the use of the word “should” refers to optional recommendations (anchored in ethicalobligations and best practices). To further aid this distinction, mandatory requirements under the EUCTR are marked with a “§” icon throughout the GLSP. In addition, to easily identify recommendations onpaediatric LS, a paediatric icon is added to relevant text sections. The Appendices offer supplemental information. Appendix 1 contains additional useful considerationsand information related to each step of the LS process. A list of glossaries is included in Appendix 2 and anumber of additional guidance references are presented in Appendix 3. Abbreviation List 1.Introduction-------------------------------------------------------------------------------------------------------------------------------- 62.Planning of the Lay Summary---------------------------------------------------------------------------------------------------- 73.Development of the Lay Summary--------------------------------------------------------------------------------------------- 94.Translation of the Lay Summary-----------------------------------------------------------------------------------------------145.Dissemination of the Lay Summary------------------------------------------------------------------------------------------15 GLSP HANDBOOK................................................................................................................... 16 1.1 Purpose & Scope of the Good Lay Summary Practice.......................................................................... 161.2 Target Audience for the Good Lay Summary Practice........................................................................... 171.3 Target Audience for the Lay Summary..................................................................................................... 181.4 Terminology and Language........................................................................................................................ 18 2.Planning of the Lay Summary---------------------------------------------------------------------------------------------------19 2.1 Timing of the Lay Summary........................................................................................................................ 192.2 Lay Summary Production Planning........................................................................................................... 202.3 Cost Implications.......................................................................................................................................... 222.4 Stakeholder Communication..................