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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Catch some highlights of the event on our youtube channel
*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
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WELCOME & KEYNOTE |
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10:00 - 10:05 |
Introduction Jacques Demotes, Director General, ECRIN |
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10:05 - 10:15 |
The choice of platform trials for the European COVID response Barbara Kerstiëns, Research & Innovation DG, European Commission |
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10:15 - 10:45 |
Keynote: The power of large simple trials Marion Mafham, Senior Research Fellow at University Of Oxford |
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10:45 – 11:00 |
Questions |
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MORNING PLATFORM TRIALS SESSION |
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11:00 - 11:15 |
Multi-domain platform trial with adaptive randomisation Lennie Derde, Intensivist And Clinician Researcher, University Medical Center Utrecht |
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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 |
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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 |
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11:45 – 12:00 |
Questions |
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AFTERNOON PLATFORM TRIALS SESSION |
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14:00 – 14:20 |
The patient perspective Valentina Strammiello, Head of Programmes, European Patient Forum |
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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
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PANEL SESSION |
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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
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CLOSING SESSION |
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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 |
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15:55 – 16:00 |
Closing message Jacques Demotes, Director General, ECRIN |
See full press release: HERE