CCI4EU (Comprehensive Cancer Infrastructures for the European Union) is a European project aiming to help Member States and Associated Countries improve or develop their existing or future Comprehensive Cancer Infrastructures (CCIs), by helping develop their research & innovation-related capacities.
This course is the second of 10 online training courses organised within the project to help countries develop an effective comprehensive infrastructure and widen the reach of this grant. The topic of this online course is: Clinical Trials and Clinical Research.
The aim is to discover how to build a successful and sustainable clinical research programme.
Target audience
People involved in management, coordinators, clinicians, researchers, directors, patients involved in clinical research.
Course delivery The first part of this course was made available on this website from 16 September 2024. The second part of this online course was held live on 15 October 2024 via this webpage. The entire course was recorded and is now available as on-demand material. To access the on-demand materials (after the live streaming), participants must register to the course, login to the e-ESO platform and click on the play buttons inside the course programme.
Official language
The course was held in English. Translations are not provided, but English subtitles can be activated and transcriptions can be automatically translated using free online tools.
Registration
Registration to the course is free but mandatory. Registration will be confirmed by e-mail.
Certificate of attendance
Participants will be issued a certificate of attendance once they have completed a minimum attendance of 75% of the entire course. An online evaluation questionnaire must be completed in order to receive the certificate that will be issued by email. The evaluation questionnaire will appear in the right-hand column of the course page when participants have completed 75% of the course.
PART 1: How to make clinical research balanced between academia and pharma-sponsored?
16/09/2024
Academic studies/commercial, which is the right proportion? - common cancers
Expert:
Richard Baird, UK
Academic studies/commercial, which is the right proportion? - rare cancers
Expert:
Silvia Stacchiotti, IT
How multidisciplinary tasks forces contribute to foster translational research
Expert:
Alejandro Piris, ES
PART 2: Clinical Research as a Fundamental Pillar of CCIs: innovation, quality control, sustainability, outcomes and PROs
16/09/2024
How do you build your network? Euracan ERN as a model
Expert:
Jean-Yves Blay, FR
How to initiate and conduct clinical trials in Europe? Protarget Study as a model trial for precision oncology
Expert:
Ulrik Lassen, DK
How to manage the usage of medical data? Step forward to data federation based on IDEA4RC project
Expert:
Annalisa Trama, IT
PART 3: How to navigate the threats for clinical research in Europe?
16/09/2024
How to harmonise the processes for assessment and supervision of clinical trials throughout the EU? The pros and cons of the EU CTR
Expert:
Scott Greenfeder, US
How does IVDR affect clinical research in Europe?
Expert:
Dario Trapani, IT
How do you conduct/finance academic studies with a molecular pre-screening programme and drug supply?
Expert:
Carlos Lopez, ES
LIVE STREAMING
15/10/2024
Introduction and welcome
15/10/2024
Chairs:
Iwona Lugowska, PL - Josep Tabernero, ES
PART 1: How to make clinical research balanced between academia and pharma-sponsored?
15/10/2024
Summary
Expert:
Josep Tabernero, ES
Discussion
Experts:
Jean-Yves Blay, FR - Rachel Giles, NL - Josep Tabernero, ES - Winette van der Graaf, NL
Moderator:
Iwona Lugowska, PL
PART 2: Clinical Research as a Fundamental Pillar of CCIs: innovation, quality control, sustainability, outcomes and PROs
15/10/2024
Summary
Expert:
Iwona Lugowska, PL
Discussion
Experts:
Elena Garralda, ES - Rachel Giles, NL - Iwona Lugowska, PL - Mef Nilbert, SE
Moderator:
Josep Tabernero, ES
PART 3: How to navigate the threats for clinical research in Europe?
15/10/2024
Summary
Expert:
Josep Tabernero, ES
Discussion
Experts:
Rachel Giles, NL - Francesco Pignatti, NL - Josep Tabernero, ES - Ana Zanoletty, NL - Jan-Willem van de Loo, BE
Moderator:
Iwona Lugowska, PL
PART 4: Example cases
15/10/2024
Western Europe experience
Expert:
Maud Kamal, FR
Eastern Europe experience
Expert:
Piotr Rutkowski, PL
Take home message and closing remarks
15/10/2024
Chairs:
Iwona Lugowska, PL - Josep Tabernero, ES
Richard Baird
Academic Consultant in Experimental Cancer Therapeutics,
Cancer Research UK Cambridge Centre, University of Cambridge,
Cambridge,
United Kingdom
Jean-Yves Blay
Université Claude Bernard Lyon & Centre Léon Bérard,
Lyon,
France
Elena Garralda
Codirector VHIO Clinical Research Program,
Vall d’Hebron Institute of Oncology,
Barcelona,
Spain
Rachel Giles
President,
VHL Europa,
Amsterdam,
The Netherlands
Scott Greenfeder
VP Head Oncology Regulatory Strategy Nucleus,
Bayer USA,
Whippany NJ,
USA
Maud Kamal
Executive Director,
Institut Hospitalo Universitaire PRISM - Gustave Roussy Cancer Campus,
Paris,
France
Ulrik Lassen
Head of Oncology Department,
Rigshospitalet,
Copenhagen,
Denmark
Carlos Lopez
Vall d’Hebron Institute of Oncology,
Barcelona,
Spain
Iwona Lugowska
Head of International Cooperation,
MSC National Research Institute of Oncology,
Warsaw,
Poland
Mef Nilbert
Lund University,
Lund,
Sweden
Francesco Pignatti
Scientific Adviser for Oncology,
European Medicines Agency,
Amsterdam,
The Netherlands
Alejandro Piris
Head of the Scientific Coordination/Management Area,
Vall d’Hebron Institute of Oncology,
Barcelona,
Spain
Piotr Rutkowski
Plenipotentiary of Head Director for National Oncological Strategy and Clinical Trials,
Maria Sklodowska-Curie National Research Institute of Oncology,
Warsaw,
Poland
Silvia Stacchiotti
National Cancer Institute - IRCCS Foundation,
Milan,
Italy
Josep Tabernero
Vall d'Hebron University Hospital,
Barcelona,
Spain
Annalisa Trama
National Cancer Institute - IRCCS Foundation,
Milan,
Italy
Dario Trapani
European Institute of Oncology,
Milan,
Italy
Jan-Willem van de Loo
Cancer Theme Lead, Senior Expert Cancer Research and Innovation,
European Commission,
Brussels,
Belgium
Winette van der Graaf
Head of Medical Oncology Department,
Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute; Erasmus Medical Center,
Amsterdam,
The Netherlands
Ana Zanoletty
Head of Clinical Trials Transformation,
European Medicines Agency,
Amsterdam,
The Netherlands