EU-PEARL logo

FACTS & FIGURES

Start Date
End Date
Call
IMI2 - Call 15
Grant agreement number
853966

Type of Action: 
RIA (Research and Innovation Action)

Contributions
IMI Funding
12 004 953
EFPIA in kind
11 957 083
Associated Partners
2 276 012
Total Cost
26 238 048

Summary

In a conventional clinical trial, typically half of the people participating in the trial receive the drug under investigation, and half receive a placebo. Trials may last years and cost a lot of money. In addition, if there are many trials in a disease area, it can be hard to find enough patients for all the trials taking place at a given time. For their part, patients struggle to find the right trial for their needs.

EU-PEARL aims to revolutionise the way we do clinical trials by making them more efficient and patient friendly. The project team will do this by setting up adaptive clinical trial platforms which allow multiple companies to test their candidate drugs simultaneously against a shared placebo group. Furthermore, in an adaptive platform trial with a single master protocol, new treatment groups can be added at any time, and candidate drugs that prove ineffective can be dropped. This will make it easier to enrol enough patients, while patients will benefit from an increased likelihood of being allocated a promising treatment instead of the placebo.

EU-PEARL will build the platform on a number of pillars. A clinical network of hospitals will provide the environment for the clinical trials and a place where different stakeholders can come together and interact. Patients are partners in the project and will contribute to the design of the platforms. EU-PEARL will also develop a comprehensive set of tools and methods for the planning, implementation and analysis of the trials. Finally, it will address regulatory issues as well as data governance.

EU-PEARL will focus its efforts on four disease areas: major depressive disorder, tuberculosis, the liver disease non-alcoholic steatohepatitis (NASH), and neurofibromatosis. However, the project outputs will make it possible to set up similar trial platforms in other disease areas in the future.

Achievements & News

The WHO’s COVID-19 clinical trial is ‘adaptive’. What does that mean?
November 2020

The record for the fastest vaccine ever developed is about four years from lab to patient. The new coronavirus vaccines are set to smash this record. In some cases, it will be thanks to the use of adaptive trial platforms, which are trials that run studies of multiple drugs at the same time and ‘pool’ the placebo group.###

While adaptive trial design is extremely good at reducing drug development times, it is also very complex. That’s why in 2019, IMI launched EU-PEARL to help provide the evidence and support for those who want to design their own adaptive trials, with the ultimate aim of getting medicines more quickly to market.  

EU-PEARL’s partners include some of the world’s foremost experts in adaptive platform trials. These experts were consulted by the World Health Organisation during the design phase of the Solidarity trial, a study to test multiple COVID-19 treatment, diagnostic and prevention options, including vaccines. New treatment groups can be added at any time, where necessary, and candidate compounds that don’t work can be dropped.

Though the adaptive trial concept has existed for years, there is still lack of uniformity and understanding as to what an adaptive platform means and how it works in practice. ‘The process of designing and running these trials is incredibly complex,’ says EU-PEARL project lead Ann Van Dessel of Johnson & Johnson. ‘To support researchers who decide to take on the task, we are putting in place the tools that are necessary to make sure they succeed. The project will set up a new entity whose job it will be to help facilitate these very complex new studies, and to maintain the tools and guidelines developed during the project.’

Find out more

Participants Show participants on map

EFPIA companies
  • Allergan Limited, Marlow, United Kingdom
  • Astrazeneca AB, Södertälje, Sweden
  • Institut De Recherches Internationales Servier Iris, Suresnes, France
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Novartis Pharma AG, Basel, Switzerland
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Otsuka Novel Products GMBH, Munich, Germany
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Teva Pharmaceutical Industries Limited, Netanya, Israel
Universities, research organisations, public bodies, non-profit groups
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Bundesinstitut Fur Impfstoffe Und Biomedizinische Arzneimittel, Langen, Germany
  • Charite - Universitaetsmedizin Berlin, Berlin, Germany
  • Eatris Eric, Amsterdam, Netherlands
  • Ecrin European Clinical Research Infrastructure Network, Paris, France
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • Euroscan International Network Ev, Koln, Germany
  • Forum Des Patients Europeens, 1040, Belgium
  • Fundacio Hospital Universitari Vall D'Hebron - Institut De Recerca, Barcelona, Spain
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • King'S College London, London, United Kingdom
  • Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany
  • Medizinische Universitaet Wien, Vienna, Austria
  • The European Institute For Innovation Through Health Data, Gent, Belgium
  • The University Of Manchester, Manchester, United Kingdom
  • Universita Degli Studi Di Milano, Milano, Italy
  • Universita Vita-Salute San Raffaele, Milano, Italy
  • University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
  • University of Oxford, Oxford, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Berry Consultants Llp, London, United Kingdom
  • Custodix Nv, Sint-Martens-Latem, Belgium
  • Documental Ou, Tallinn, Estonia
  • Team - It Research SL, Barcelona, Spain
Patient organisations
  • European Patients’ Forum (EPF), Brussels, Belgium
Associated partners
  • Children'S Tumor Foundation, New York, United States
  • Global Alliance For Tb Drug Development Non Profit Organisation, New York, United States
  • Springworks Therapeutics Inc, Stamford, United States
Project coordinator
Joan Genescà
Fundacio Hospital Universitari Vall D'Hebron - Institut De Recerca
Project leader
Ann Van Dessel
Janssen Pharmaceutica Nv