The EU Clinical Trials Regulation:

Improving clinical research for children and adolescents in Europe?

Hosted by MEP Glenis Willmott, MEP

Wednesday, 20^th February 2013

Photos from the event

Summary report

Presentations from the speakers

Programme

Every year SIOPE organizes a high-level meeting at the European Parliament in Brussels to mark International Childhood Cancer Day (15 February). This year the topic focused on the proposal by the European Commission for a Clinical Trials Regulation following the huge regulatory burden of the EU Clinical Trials Directive (2001/20/EC).

There is real potential for this burden to be reversed by the legislative proposal, which is currently being assessed by Member States (Council) and the European Parliament.

The principle objective of trials for children and young people with cancer is treatment optimisation using well-established chemotherapy drugs, and the introduction of new, safe and effective innovative medicine in standard care. These trials are non-commercial, sponsored and conducted by academic institutions and funded by public money and/ or charity support to cover the trials’ organisational structures.

A pragmatic approach to trial governance for children and adolescents with cancer in Europe is needed. Therefore on this occasion, SIOPE and ENCCA, the European Network for Cancer research in Children and Adolescents, on behalf of the European paediatric oncology community, call for:

• FAIR and proportionate regulation of childhood cancer trials, where the aim is to improve survival using medicinal products that are already in common use
• FAIR and proportionate insurance for academic trialstreating children with rare diseases, secured through the proposed ‘national indemnity schemes’.

• Read our position
• Read our proposed amendments

SIOPE and Member of the European Parliament (MEP) Glenis Willmott, the Rapporteur of the EU Clinical Trials Regulation proposal, invited experts and decision-makers to discuss key aspects of the Regulation. Exceptionally this year, experts from other paediatric diseases joined the meeting and provide their perspective on the new legislation. We are delighted that members of Enpr-EMA the European Network of Paediatric Research at the European Medicines Agency joined and a lively and forward-looking discussion on how to improve clinical research for children and adolescents in Europe took place.

Presentations from the speakers:

• Introduction of the meeting
• Patricia Blanc, Imagine for Margo (parent) - The importance of clinical research for our children
• Peter Helms, Chair, EnprEMA, ScotCRN - Advancing paediatric clinical research in Europe: an overview
• Gilles Vassal, SIOPE President, Institut Gustave Roussy - Ensuring the best possible care and outcome for children and young people with cancer in Europe
• Pam Kearns, ECRC Vice-Chair, University of Birmingham - Low-intervention proposal: Issue Overview
• Kris De Boeck, ECFS Clinical Trials Network, Leuven University - Case Study: Paediatric Cystic Fibrosis
• Ruth Ladenstein, ENCCA Project Coordinator, ECRC Chair, St. Anna Children’s Hospital - Issues Overview
• Nicola Ruperto, PRINTO, Istituto Giannina Gaslini - Case Study: Paediatric rheumatology diseases
• Anneke Gommers, patient, ECFS Clinical Trials Network - Moving research forward for the next generation of children and young people
  

Photos from the event: