International Clinical Trials Day (ICTD) 2021

 

ICTD 2021: Platform Trials: Shift in Treatment, Testing and Collaboration

In light of the current pandemic, ECRIN is organising a virtual event for International Clinical Trials Day (ICTD) on May 20th, 2021. ICTD 2021 will bring together stakeholders from across Europe and the globe to discuss the growing interest in platform trials from best practices to challenges in the European context. ICTD is open to research organisations, clinical research professionals, patient organisations, regulatory and ethics bodies, funders and industry. 

Platform trials

Platform trials, sometimes known as adaptive platform trials, allow a multitude of different treatment options (arms) to be compared with a single control (arm). They enable ineffective arms to be stopped after an interim analysis. To date, they have been used principally in the field of oncology and more recently infectious diseases. They represent the clinical approach selected by the European Commission to find a treatment for COVID-19. 

This new trial format raises many questions, changes our approach to conducting clinical trials and testing for appropriate treatments. Through this online conference, we hope to help you answer some of the following questions:

  • What are the underlying objectives of a platform trial?
  • Which parameters must be considered in the design, statistical plan and data management?
  • How should one address regulatory and ethical issues as well as the involvement of patients?
  • What types of management, economic and governance concerns may be encountered when we use this trial model?

The virtual event (10:00 – 16:00 CEST) is free and open to all.

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*Access to full event archives are accessible to those who registered on the virtual stage. You must login (see button above) as you did to view the event and the links are now located in the programme on the left-hand toolbar. They will be available until the end of September. 

You can view the full ICTD 2021 agenda or access a pdf: here

WELCOME & KEYNOTE

10:00 - 10:05

Introduction

Jacques Demotes, Director General, ECRIN

10:05 - 10:15

The choice of platform trials for the European COVID response

Barbara Kerstiëns, Research & Innovation DG, European Commission

10:15 - 10:45

Keynote: The power of large simple trials

Marion Mafham, Senior Research Fellow at University Of Oxford

10:45 – 11:00

Questions

MORNING PLATFORM TRIALS SESSION

11:00 - 11:15

Multi-domain platform trial with adaptive randomisation

Lennie Derde, Intensivist And Clinician Researcher, University Medical Center Utrecht

11:15 – 11:30

Considerations when developing a platform trial in Europe during a pandemic

Marius Trøseid, Associate Professor And Senior Consultant, Oslo University Hospital

11:30 – 11:45

Recommendation on operational challenges of platform trials

Sharon Love, Associate Professor, Trial Conduct Methodology at MRC Clinical Trials Unit, University College London

Francesca Schiavone, Clinical Project Manager, Phd, MRC Clinical Trials Unit, University College London

11:45 – 12:00

Questions

 

 

AFTERNOON PLATFORM TRIALS SESSION

14:00 – 14:20

The patient perspective

Valentina Strammiello, Head of Programmes, European Patient Forum

14:20 – 14:40

Effects of platform trials on the research team

Liz Morrell, Senior Researcher, Health Economics Research Centre, Nuffield Department Of Population Health, University Of Oxford

 

PANEL SESSION

14:40 – 15:40

Statistical, regulatory & ethical issues related to the trial, its design and implementation Multi-domain platform trial with adaptive randomisation

Chair: Joan Genescà, Professor Of Medicine, Chief Liver Unit, Hospital Universitari Vall D’hebron, Universitat Autònoma De Barcelona

 

Panelists:

Cecile Spiertz, Senior Director, External Innovation Clinical Trial Platforms, Johnson & Johnson

Fergus Sweeney, Head, Clinical Studies and Manufacturing Taskforce, European Medicines Agency

Frank Hulstaert, Senior Researcher, Belgian Health Care Knowledge Centre (KCE)

Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy, European Medicines Agency

Martin Posch, Professor, Medical University Of Vienna

Valentina Strammiello, Head of Programmes, European Patient Forum

 

CLOSING SESSION

15:40  - 15:55

EMA Clinical Trial Information System (CTIS) for platform trials

Noémie Manent, Principal Scientific Administrator, Clinical Studies And Manufacturing Task Force, European Medicines Agency

15:55 – 16:00

Closing message

Jacques Demotes, Director General, ECRIN

 

 

See full press release: HERE