CCI4EU - Clinical trials and clinical research



Chairs: Iwona Lugowska, PL - Josep Tabernero, SP
 
Introduction
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.

Organising secretariat
Sarah Jennie Goldman: sgoldman@eso.net
Francesca Marangoni: fmarangoni@eso.net
Sonia Bulgarelli: sbulgarelli@eso.net
 

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