Annual Conference 2021 - Clinical Research Value and Transparency
How to capitalise on the post-pandemic opportunities?
Description
| 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.
Programme
| 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 |
| 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 |
| 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 |
|
SESSION 1 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 |
|
SESSION 2 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 |