Implementing "Good Lay Summary Practice"

The “Roadmap Initiative to Good Lay Summary Practice” aims to develop a pragmatic, broadly accepted framework for LS planning, development, translation and dissemination.

Workshop Workshop
14, 15 & 21 Feb. 2022 14, 15 & 21 Feb. 2022
4 hours 15 4 hours 15
Presentations & Recordings: Available for Event's Registered Participants only Presentations & Recordings: Available for Event's Registered Participants only

Description

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 multi-stakeholder 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.
Day 1 - Monday 14th of February 2022
13:30 Welcome and Introduction to the GLSP Development Process
Silvia Garcia, EFPIA
Ingrid Klingmann, EFGCP
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
Thomas Schindler, Former Boehringer-Ingelheim, Lay & Regulatory Writing
Solange Corriol-Rohou, AstraZeneca
15:30 Break
Session 2: Hopes and expected hurdles for implementation of GLSP
Chairs: DK Theo Raynor, Professor Emeritus, University of Leeds Souzi Makri, CYLPER
15:45 Lay Summaries in academia and publicly funded studies - Discussion
Christine Kubiak, ECRIN
16:30 Patients’ viewpoint – Discussion
Sandrine Lavalle, LIH
17:15 Lay Summaries in global companies for global studies – Discussion
Julie Holtzople, AstraZeneca
17:45 End of Day 1

Day 2 - Tuesday 15th of February 2022
13:30 Welcome and introduction to today’s programme
Silvia Garcia, EFPIA
Ingrid Klingmann, EFGCP
14:30 Parallel Break-out Sessions (BOs) - Block 1
Break-out 1: How to make patient involvement in GLSP work in reality?
Margit Paul, Hepatitis Hilfe Austria
Laura Hagan, Novartis
Break-out 2: Lay Summary translations – Needs, complexity, and suitability
Pia Windelov, LionBridge
John Linnell, US COPD Coalition
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 Hospital
Solange Corriol-Rohou, AstraZeneca
Nicola Ruperto, PRINTO
Behtash Bahador, CISCRP
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
Margit Paul, Hepatitis Hilfe Austria
Pia Windelov, LionBridge
Begonya Nafria Escalera, San Joan de Déu Hospital
Debra Guerreiro, Janssen R&D
17:45 End of Day 2

Day 3 - Monday 21st of February 2022
13:30 Welcome and introduction to today’s programme
Silvia Garcia, EFPIA
Ingrid Klingmann, EFGCP
13:40 Feedback from Break-out Sessions
BoS 1 - Feedback
Margit Paul, Hepatitis Hilfe Austria
BoS 2 - Feedback
Pia Windelov, LionBridge
BoS 3 - Feedback
Begonya Nafria Escalera, San Joan de Déu Hospital
BoS 4 - Feedback
Debra Guerreiro, Janssen R&D
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
Chairs: Ingrid Klingmann, EFGCP Silvia Garcia, EFPIA
Maria Alexandra Ribei, CEIC, CTEG
Edit Szepessy, DG Santé
Nicola Ruperto, PRINTO
Kaisa Immonen, EPF
Laura Hagan, Novartis
Thomas Schindler, formally Boehringer-Ingelheim, Lay & Regulatory Writing
Pia Windelov, LionBridge
Solange Corriol-Rohou, AstraZeneca
Increasing trust: Priority activities for successful implementation of GLSP
Edit Szepessy, DG Santé
Increasing trust: Priority activities for successful implementation of GLSP
Nicola Ruperto, PRINTO
17:45 Conclusions and next steps
Silvia Garcia, EFPIA
Ingrid Klingmann, EFGCP