Implementing Good Lay Summary Practice

A pragmatic framework for LS planning, development, translation and dissemination

Description

Event Workshop
Type Virtual Event
Language English
Date(s) 14, 15 & 21 Feb. 2022
Day(s) 3 Day(s)
Duration 4 hours/ day

The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical trial results from commercial and non-commercial sponsors.

Over 60 participants from EU and US pharmaceutical companies, CROs, academic institutions, patient organisations, and not-for-profit organisations have created the “Roadmap Initiative to Good Lay Summary Practice” with the aim to develop a pragmatic, broadly accepted framework for Lay Summary planning, development, translation and dissemination. Building on experience and documents that are already available, this Roadmap Initiative created a draft guideline based on the work and pragmatic solution proposals of 5 multistakeholder Task Forces. After integration of the comments from a broad public consultation the draft recommendations were further developed together with The European Commission’s Expert Group on Clinical Trials (CTEG). In July 2021 the final text was adopted by CTEG and on 04 October 2021 the European Commission published the “Good Lay Summary Practice Guideline” in EudraLex Volume 10. To ensure that suitable Lay Summaries become reliably available to patients and the public the Roadmap Initiative to Good Lay Summary Practice decided to jointly work on the second important step: the implementation of this standard in the collaboration between all involved stakeholders. This requires broad awareness about this new standard and multi-stakeholder discussion about expected hopes and hurdles for its implementation. Jointly worked-out proposals for most suitable and needed implementation activities need to be developed now.

In this virtual 3 afternoons Workshop the key content of GLSP will be presented and hopes and hurdles for its implementation raised on Day 1. On Day 2 participants will be able to join 2 out of 4 Break-out Sessions of their choice in which concrete proposals will be worked out on how best to prepare our communities for the respective particularly challenging aspects of GLSP. On Day 3 the results from these Break-out Sessions will be presented, jointly discussed and conclusions proposed to inspire the European Commission’s and the Roadmap’s second important objective: the implementation of GLSP in clinical research daily practice including training opportunities for all involved stakeholders.

Programme

Monday 14 February 2022
13:30 Welcome and Introduction to the GLSP Development Process
Ingrid Klingmann, EFGCP
Silvia Garcia, EFPIA
Session 1 - GLSP, the new standard to ensure information on clinical trial results that is understandable to patients and the public
13:40 The European Commission’s strategy to enhance transparency on clinical trial results to patients and the public
Sylvain Giraud, European Commission DG Santé
14:00 Good Lay Summary Practice: - The new standard’s principles - The planning - The development - The translation - The dissemination
Solange Corriol-Rohou, AstraZeneca
Thomas Schindler, formally Boehringer-Ingelheim, Lay & Regulatory Writing
15:30 Break
Session 2 - Hopes and expected hurdles for implementation of GLSP DK Theo Raynor, Professor Emeritus, University of Leeds Souzi Makri, CYLPER
15:45 Lay Summaries in academia and publicly funded studies
Christine Kubiak, ECRIN
16:30 Patients’ viewpoint
Sandrine Lavalle, LIH
17:15 Lay Summaries in global companies for global studies
Julie Holtzople, AstraZeneca
17:45 End of Day 1
Tuesday 15 February 2022
13:30 Welcome and introduction to today’s programme
Ingrid Klingmann, EFGCP
Silvia Garcia, EFPIA
13:40 Parallel Break-out Sessions (BOs) - Block 1
Break-out 1: How to make patient involvement in GLSP work in reality?
Laura Hagan, Novartis
Margit Paul, Hepatitis Hilfe Austria
Break-out 2: Lay Summary translations – Needs, complexity, and suitability
John Linnell, US COPD Coalition
Pia Windelov, LionBridge
15:30 Break
15:50 Parallel Break-out Sessions (BOs) - Block 2
Break-out 3: How to make Lay Summaries in paediatric studies the new norm?
Begonya Nafria Escalera, San Joan de Déu
Behtash Bahador, CISCRP
Nicola Ruperto, PRINTO
Solange Corriol-Rohou, AstraZeneca
Break-out 4: Approaches to the dissemination of Lay Summaries
Debra Guerreiro, Janssen R&D
Thomas Schindler, formally Boehringer-Ingelheim, Lay & Regulatory Writing
17:30 Feedback on highlights from the Break-out Sessions
Begonya Nafria Escalera, San Joan de Déu
Debra Guerreiro, Janssen R&D
Margit Paul, Hepatitis Hilfe Austria
Pia Windelov, LionBridge
17:45 End of Day 2
Monday 21 February 2022
13:30 Welcome and introduction to today’s programme
Ingrid Klingmann, EFGCP
Silvia Garcia, EFPIA
13:40 Feedback from Break-out Sessions 1,2,3, and 4 Kerstin Breithaupt-Grögler, AGAH Maria Dutarte, EUPATI
Begonya Nafria Escalera, San Joan de Déu
Debra Guerreiro, Janssen R&D
Margit Paul, Hepatitis Hilfe Austria
Pia Windelov, LionBridge
15:40 Break
15:55 How will EMA and CTIS fulfil the need for fair access to lay summaries in Europe and beyond?
Fergus Sweeney, EMA
16:25 Panel and plenary discussion Increasing trust: Priority activities for successful implementation of GLSP Ingrid Klingmann, EFGCP Silvia Garcia, EFPIA
Edit Szepessy, DG Santé
Kaisa Immonen, EPF
Laura Hagan, Novartis
Maria Alexandra Ribeiro, CEIC, CTEG
Nicola Ruperto, PRINTO
Pia Windelov, LionBridge
Solange Corriol-Rohou, AstraZeneca
Thomas Schindler, formally Boehringer-Ingelheim, Lay & Regulatory Writing
17:45 Conclusions and next steps
Ingrid Klingmann, EFGCP
Silvia Garcia, EFPIA