SIOPE has been proactively engaged in advocating effective changes to European clinical trials legislation. Last year, the European Commission has proposed a new EU Clinical Trials Regulation (CTR), which aims to address many of the problems clinical trialists face in their daily work. Our Society still has something to say as concerns this Regulation, currently in the last phase of the EU decision-making process. The European Parliament and Council are reviewing the legislation and providing amendments to the Commission’s proposal. To date, SIOPE has also proposed its amendments to this piece of legislation, which mainly focus on three simple messages:
- Fair and proportionate risk categorisation of childhood cancer trials, where the use of medicinal products is often outside the terms of the marketing authorisation (off-label use) but is based on high-level expertise, standard practice and decades of success.
- Fair insurance for academic trials treating children with rare diseases, secured through ‘national indemnity schemes’.
- Fair and proportionate transparency measures, with provisions for reasonable and secure reporting that protects young cancer patients and their personal data.