International Clinical Trials Day (ICTD) 2021
Due to the Covid-19 pandemic, ECRIN organised ICTD 2021 as an online, virtual event on May 20th, 2021. ICTD 2021 brought 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.
About 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 answering 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?
Discover the ICTD 2021 agenda and videos below.
Opening session ICTD 2021
|Prof. Dr. Jacques Demotes
Director General, ECRIN
|Welcome and opening statement of ICTD 2021||
|Dr. Barbara Kerstiëns, MD, MPH
Head of Unit Combatting Diseases, European Commission
|The choice of platform trials for the European COVID response||
|Dr. Marion Mafham
Nuffield Department of Population Health, University of Oxford
|Keynote: The power of large simple trials||
Platform trials – Examples and lessons learned
|Dr. Lennie Derde, MD
|Multi-domain platform trial with adaptive randomisation||
|Dr. Marius Trøseid, MD, PhD.
Associate Professor, Senior consultant, University of Oslo
|Considerations when developing a platform trial in Europe during a pandemic||
|Prof. Sharon Love
University College London
|Recommendation on operational challenges of platform trials||
|Francesca Schiavone, PhD.
Clinical Project Manager, MRC Clinical Trial Unit
Head of Programmes, European Patients Forum
|A patient perspective on platform trials||
|Sr. Researcher Liz-Morrell
Health Economics Research Centre, University of Oxford
|Effects of platform trials on the research team (*)||
Chair Dr. Joan Genescà (Hospital Universitari Vall d'Hebron)
Marco Cavalieri (EMA)
Fergus Sweeney (EMA)
Martin Posch (MedUni Wien)
Franck Hulstaert (KCE)
Cecile Spiertz (The Janssen Pharmaceutical Company)
Valentina Stramiello (European Patients Forum)
|Statistical, regulatory & ethical issues related to the trial, its design and implementation|
Compliance and Inspection Sector, European Medicines Agency
|Clinical Trial Information System (CTIS) for platform trials||
|Prof. Jacques Demotes
Director General, ECRIN
|Closing remarks ICTD2021||