Annual Conference 2021 - Clinical Research Value and Transparency

How to capitalise on the post-pandemic opportunities?


Event Conference
Type Virtual Event
Language English
Date(s) 13, 14, 16 & 17 Dec. 2021
Day(s) 4 Day(s)
Duration 4 hours/ day

2020 and 2021 have changed the public’s and researchers’ attitude on value of clinical research and its transparency. Both used to be a ”Nice to have” and subject to good intentions but our experiences during the COVID-19 pandemic showed us the fundamental need for and benefits of clinical research excellence and reliable transparency for understanding the situation, making decisions and handling our way of living. And we have experienced a quantum leap in public interest in clinical research, biomedical research topics, methodologies and results.

The EFGCP Annual Conference 2021 will provide the platform for multi-stakeholder discussions of the changes we are currently facing and for jointly finding more efficient ways to better fulfil the clinical research and transparency needs of patients and the public in the development of new prophylactic and treatments options from finding trials to reporting of results.

Due to the special situation during the pandemic and the many current changes this EFGCP Annual Conference will go new ways in jointly enabling virtual global expert exchange and solution finding. We would very much appreciate if you would join us for the full conference as all topics are very relevant and we would all benefit from an ongoing, joint discussion. However, participants can book days individually.


Finding out about clinical research – The relevance of reliable research results and of their availability to the interested communities
14:00 Welcome and Introduction to the Conference
Ingrid Klingmann, EFGCP
14:15 Introduction to today’s programme
Alastair Kent, EFGCP
14:35 The researchers view: How to ensure high quality research and how to avoid waste, in times of a pandemic?
Simon Kolstoe, University of Portsmouth, UK
15:10 The patient’s view: Options and hurdles for patients to find reliable clinical trial results when flooded with information during the COVID-19 pandemic
Tamás Bereczky, Patvocates
15:45 The importance of enabling transparency on clinical trials between competent authorities and the public, especially in times like the COVID-19 pandemic
Noel Wathion, Retired
16:20 Break
16:35 Future options for improving research transparency
IMI PharmaLedger: Blockchain solutions to improve transparency and trust in clinical research
Stephen Leiper, Onorach
EFPIA Oncology Platform and EFGCP: Needs in facilitating cross-border access to clinical trials
Ivana Cattaneo, Novartis
Teodora Lalova, KU Leuven
18:05 Summary from the day and future steps
Ingrid Klingmann, EFGCP
18:15 End of Day 1
Patient involvement for improvement of clinical research and transparency: Today’s reality?
13:00 Introduction to today’s programme: What we want to achieve
Lynne Van Poelgeest-Pomfret, EFGCP
13:05 Patient involvement 10 years after starting EUPATI: Are patients now involved?
Jan Geissler, Patvocates
13:40 Experience with patient engagement in R&D processes during the pandemic
Donatella Decise, Novartis
14:15 EMA’s patient engagement strategy during the pandemic
Juan Garcia Burgos, EMA
14:50 Break
15:05 Investment and outcome in EU patient engagement projects: Have clinical research and transparency improved?
An IMI perspective
Pierre Meulien, IMI
A patient organisation perspective
Anders Olauson, Agrenska
An industry perspective
Katherine Capperella, Janssen
16:05 Panel and Open Forum Discussion: How to maximise the value of patient engagement for improving research quality and transparency in a post-COVID-19 world?
Dipak Kalra, i-Hd
16:45 Joseph Hoet Lecture on Ethics in Clinical Research 2021
David Haerry, EATG
17:05 Summary from the day and future steps
Eric Klasen, EFGCP
17:15 End of Day 2
Modern problems around informed consent
14:00 Introduction to today’s programme: Informed Consent processes must be transparent, honest and helpful: what are today’s problems?
Heather Sampson, EFGCP
14:10 The Evidence
Katie Gillies, University of Aberdeen
14:25 The Patient’s perspective
Jo Gumbs, OcumelUK
14:40 The Sponsor’s perspective
Daniella Frisoli, Roche
14:55 The Research Ethics Committee’s perspective
Lee Potiphar, University of Gloucestershire
15:15 Joint Discussion
Moderator(s): Heather Sampson, EFGCP
16:00 Break
Specific areas of concern
16:20 Developing investigators’ competence in this area: how to avoid unnecessary nocebo harms
Jeremy Howick, University of Oxford
16:35 Improving investigators’ competence in meeting paediatric patients’ individual information needs
Begonya Nafria Escalera, SJD
16:50 eConsent: opportunities & challenges
Hilde Vanaken, TCS; Former Transcelerate eConsent Lead & JnJ eConsent Founder
17:05 Informed consent in global studies: Between regulatory requirements and relevance to patients
Hugh Davies, Oxford “A” REC
17:20 Joint Discussion
Moderator(s): Ingrid Klingmann, EFGCP
18:05 Summary from the day and future steps
Hugh Davies, Oxford “A” REC
18:15 End of Day 3
The way to true transparency on clinical trial results
Kerstin Breithaupt-Grögler, AGAH Solange Corriol-Rohou, AstraZeneca
14:00 Introduction to today’s programme: The need for result information that is understandable and reaches patients and the public
Dominique Hamerlijnck, ZonMW, EUPATI Fellow
14:15 The EU Commission’s approach to establishing and publishing “Good Lay Summary Practice” Recommendations
Edit Szepessy, DG Santé
14:40 Patient expectations for reliable research result information when wanted
Sandrine Lavallé, EUPATI Fellow
15:05 Relevance of lay summary availability in patients’ mother tongue: the role of a pragmatic approach to lay summary translations
Pia Windelov, LionBridge
15:30 Break
Ingrid Klingmann, EFGCP Silvia Garcia, EFPIA
15:45 How to ensure quality and objectivity of Lay Summaries, to be prepared within 12, respectively 6 months after last patient out?
Thomas Schindler, Boehringer Ingelheim
16:10 Needs and hurdles for enabling study result transparency in academic and publicly funded trials
Sabine Kläger, ECRIN
16:35 How to get lay summaries to patients and the public?
CTIS, the EU Database as the central hub for clinical trial result information to patients and the public
Fergus Sweeney, EMA
Laura Pioppo, EMA
Benefits and hurdles of direct to patients dissemination of lay summaries
Helena Glasová, Slovak Medical University
Jozef Glasa, Slovak Medical University
Options, benefits and hurdles to indirect dissemination of lay summaries nationally and globally
Debra Guerreiro, Janssen
17:35 Panel and open forum discussion: How to enable maximum outreach of lay summaries to patients and the public?
18:10 Closing remarks
18:15 End of the conference