On 2nd April 2014 the Clinical Trial Regulation (CTR) has been adopted by the European Parliament (594 votes in favour, 17 against and 13 abstentions). SIOPE and the whole paediatric oncology community would like to thank the CTR Rapporteur, MEP Ms. Glenis Willmott, for all her essential support in improving this piece of legislation.
Childhood cancer is a rare disease, fortunately. However, it remains the first cause of death by disease beyond the age of one year in Europe and every day some 250 children around the world lose their lives to cancer, a number which is staggering given the fact that 70% of all childhood cancers are curable. Children with cancer need to be protected: it is only thanks to clinical trials if the cure-rate made considerable progresses over the past 40 years, and clinical trials are vital to improve the availability and the outcome of treatments for children and adolescents with cancer. Clinical trials are also essential as concerns the adaptation of the medicines developed for adults to the use in children.
To advance research however is not easy. Because of the low number of paediatric cancer patients, pharmaceutical companies normally do not invest in drugs for this category of patients. Moreover, due to the rare nature of the disease, research to develop new treatments has to be made at the pan-European level, through multinational clinical trials. Finally, the current bureaucratic workload to trial activation is much too high for paediatric oncology trials, which are mainly investigator-led and sponsored by public universities that cannot always afford the costs and lengthy bureaucracy linked to multinational trials in children. You can read more on clinical trials here.
Since the creation of our Society, our efforts focused on these important challenges. The exaggerate bureaucracy seriously impeding the conduct of clinical trials in Europe derives from the EU Clinical Trial Directive of 2001: although the objective of the Directive was to standardise clinical trials and their quality, it resulted in a disproportionately negative effect on childhood cancer trials, due to the greatest variability in the national interpretation and a significant duplication of efforts and resources invested by the clinical trial groups to meet its requirements.
Today, the ‘Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use in Europe‘ finally repealed the Directive. SIOPE could intervene in several meetings organised by the European institutions as a key stakeholder in this process.Currently, we are deeply involved in the discussions that followed the adoption of the new Regulation, making sure that our priorities are always correctly represented (also by regularly consulting the European Clinical Research Council for paediatric oncology, the collective voice of European clinical trials’ groups and paediatric oncology national societies).
- SIOPE Response to the European Commission consultation on ‘Ethical considerations for clinical trials on medicinal products conducted with minors’ (31 Aug 2016)
- SIOPE response to EMA consultation on ‘ Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014” (Feb 2015)
- SIOPE response to EMA consultation on ‘Draft Functional specifications for the EU portal and EU database to be audited’ (Oct 2014)
- SIOPE response to the EP resolution on the EU Clinical Trial Regulation (Sept 2013)
- SIOPE position on the EP resolution on the EU Clinical Trial Regulation (Aug 2013)
- SIOPE-ENCCA-ICCCPO Manifesto on Paediatric Oncology
- More SIOPE publications on the Clinical Trials Regulation
- EU legislation: