SIOPE.EU - Clinical Trials Regulation

Proposal for a EU Regulation on Clinical Trials:

SIOPE position and suggested amendments

SIOPE Statement on the EU Regulation on Clinical Trials & 10 Facts on Off-label Drug Use in Paediatrics
Read our position on the transparency of clinical trials' results in the EU Regulation
Read our proposed amendments to the EU Regulation on Clinical Trials
Read our position on the EU Regulation on Clinical Trials
SIOPE joined other European key stakeholders in a common position on the new EU Regulation on Clinical Trials: read it here
Please find here a short video on the Clinical Trials Regulation from Prof. P. Kearns and R. Ladenstein

Regulate to Medicate

The conduct of multinational clinical trials - vital to ensure optimal treatment for children with cancer – has been seriously impeded by the exaggerate bureaucracy deriving from the EU Clinical Trials Directive (CTD). Although the objective of the CTD was to standardise the regulation and quality of trials, there was a lack of coordination and significant duplication of efforts and resources invested by the clinical trial groups to meet its requirements. In particular, the CTD has had a disproportionately negative effect on trials in childhood cancer where there has been the greatest variability in national interpretation of the Directive.

Today, there is a potential for these limitations to be reversed by the proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use in Europe, meant to repeal Directive 2001/20/EC and currently debated by national ministries and Members of the European Parliament.

SIOPE has been invited by the European Commission to several meetings as a key stakeholder in this revision process, and we are deeply involved in the discussions that followed the publication of the new Regulation, making sure that our priorities are correctly represented (also by regularly consulting the European Clinical Research Council for paediatric oncology (ECRC), the collective voice of European clinical trials’ groups and paediatric oncology national societies).

Since the creation of our society, our efforts focused on making the voice of paediatric oncology heard at the European level, especially as concerns this important theme. Multinational clinical trials are vital to ensure optimal treatment for each young person diagnosed with cancer, to enable further advancement in improving outcomes, to ensure further optimisation of outcomes after treatment for each young person diagnosed with cancer and to sustain the momentum of progress developed over the past 40 years. In the eyes of patients and clinical staff in this field of practice, clinical trials and research are considered an essential component of the fight against cancer in children and young people. It is clear that clinical research should not be considered a luxury but rather a necessary tool to combat the burden of cancer. However, the current bureaucratic workload of trial activation is much too high for the many rare diseases that comprise the childhood cancers. Moreover, the rare nature of the disease results in investigator-led trials due to the lack of commercial sponsorship. Indeed, many non-commercial organisations are still unwilling to undertake the role of sponsor at a pan-European level for multinational trials in children.

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