Joint EFGCP & EFPIA Workshop

Framework Proposal for development and dissemination of results from commercial and academic studies

Description

Event Workshop
Type Face To Face
Language English
Date(s) 15 Jan. 2020
Day(s) 1 Day(s)
Duration 8 hours/ day

The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. Several large companies have already generated experience with creation of Lay Summaries and in the USA guidance on Lay Summary content have already been developed.
Also, EMA has released an Expert Group Recommendation on the content of Lay Summaries. However, there is no guidance for all types of sponsors on how best to handle the development process of Lay Summaries and how best to ensure reliable dissemination so that the ultimate goals can be achieved: increase of clinical research transparency, patients’ and public’s understanding of clinical research as well as feedback to study participants about the results of their study.
To create a suitable, mutually acceptable framework for Lay Summaries a consorted effort of all involved stakeholders is required.
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 Practices” with the aim to develop a pragmatic, broadly accepted framework for Lay Summary development, content 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.

In this one-day workshop the draft guideline resulting from the work of these 5 Task Forces will be presented and topics that are particularly controversial or difficult to decide will be presented and discussed with the multi-stakeholder audience before a final draft will be released for broad public consultation.

Programme

Wednesday 15 January 2020
08:30 Registration and Welcome coffee
09:00 Welcome
Ingrid Klingmann, EFGCP, Belgium
Sini Eskola, EFPIA, Belgium
FAMILIARISATION WITH THE INITIATIVE
09:10 Introduction to the Roadmap Initiative to Good Lay Summary Practices
Ingrid Klingmann, EFGCP, Belgium
09:20 Presentation of the draft Guideline
Lotte Klim, EUPATI Fellow, Denmark
09:50 Q&A, general comments & recommendations Ingrid Klingmann, EFGCP, Belgium
PANEL DISCUSSION ON EXTERNAL STAKEHOLDER EXPECTATIONS
10:00 What do we expect from “Good Lay Summary Practices” Guidelines? Behtash Bahador, CISCRP, USA
Barbara Bierer, MRCT Center, Harvard Medical School, USA
Dominique Hamerlijnck, Dutch Lung Foundation, The Netherlands
Edit Szepessy, European Commission, DG Santé, Belgium
Nicola Ruperto, IRCCS Istituto Giannina Gaslini, Italy
Till Bruckner, TranspariMed, United Kingdom
10:45 Coffee Break
SHORT PRESENTATIONS, Q&A, DISCUSSIONS & RECOMMENDATIONS
11:15 The role of patients in preparation and dissemination of Lay Summaries Richard Exley, Janssen, United Kingdom
Kaisa Immonen, EPF, Belgium
12:00 Lay Summary Planning for: - Primary & secondary endpoints - Complex studies Kerstin Breithaupt, AGAH, EUFEMED, Germany
Caragh Murray, Janssen, United Kingdom
12:30 Lay Summary Planning for: - Safety data - Endpoints presentation in safety trials Kerstin Breithaupt, AGAH, EUFEMED, Germany
Thomas Schindler, Boehringer Ingelheim, Germany
13:00 Lunch
SHORT PRESENTATIONS, Q&A, DISCUSSIONS & RECOMMENDATIONS
14:00 Dissemination strategies and options for Lay Summaries Laura Hagan, Novartis, USA
Barbara Bierer, MRCT Center, Harvard Medical School, USA
Debra Guerreiro, Janssen, USA
15:00 Lay Summaries of paediatric studies Solange Corriol-Rohou, AstraZeneca, France
Begonya Nafria Escalera, San Juan de Déu, Spain
15:45 Support for development and dissemination of Lay Summaries of academic studies: - Funding needs and awareness of funders - Awareness & processes in IITs Amanda Hunn, AJ Hunn Associates, United Kingdom
Sabine Kläger, ECRIN, France
16:30 Conclusions, next steps and end of the workshop
Ingrid Klingmann, EFGCP, Belgium