International Clinical Trials Day (ICTD) 2021

Platform trials: shift in testing, treatment & collaboration.

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

ICTD 2021 bannerPlatform 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?


ECRIN Discover marker 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

Jacques Demotes

Dr. Barbara Kerstiëns, MD, MPH
Head of Unit Combatting Diseases, European Commission
The choice of platform trials for the European COVID response

Barbara Kerstiens

Dr. Marion Mafham
Nuffield Department of Population Health, University of Oxford
Keynote: The power of large simple trials

Marion Mafham

 

 

Platform trials – Examples and lessons learned

Dr. Lennie Derde, MD
UMC Utrecht
Multi-domain platform trial with adaptive randomisation

Lennie Derde

Dr. Marius Trøseid, MD, PhD.
Associate Professor, Senior consultant, University of Oslo
Considerations when developing a platform trial in Europe during a pandemic

Marius Trosheid

Prof. Sharon Love
University College London
Recommendation on operational challenges of platform trials

Sharon Love

Francesca Schiavone, PhD.
Clinical Project Manager, MRC Clinical Trial Unit
Question session

Francesca Schiavone

 

 

Afternoon session

Valentina Strammiello
Head of Programmes, European Patients Forum
A patient perspective on platform trials

Valentina Stramiello

Sr. Researcher Liz-Morrell
Health Economics Research Centre, University of Oxford
Effects of platform trials on the research team (*)

Liz Morrell

 

 

Panel session

Panel Discussion
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 Joan Genesca

ICTD 2021 Panel session

 

Closing session

Noémie Manent
Compliance and Inspection Sector, European Medicines Agency
Clinical Trial Information System (CTIS) for platform trials

Noemie Manent

Prof. Jacques Demotes
Director General, ECRIN
Closing remarks ICTD2021

Jacques Demotes

 

ECRIN Discover marker Discover the ICTD 2021 highlights and quotes. and the ICTD2021 Wrap-up newsletter.