Clinical Trial Facilitation Platform: Guidance & Templates

fIn the framework of the SIOPE Strategic Plan, we propose to develop a new platform to facilitate the implementation of the research strategy of European Clinical Trial Groups (ECTGs) in Paediatric Haemato-Oncology: the Clinical Trial Facilitation (CTF) Platform. Professor Pam Kearns (UK) and Professor Maria Grazia Valsecchi (Italy) are the leaders responsible for the implementation of this innovative platform, which will help institutions to set up international clinical trials in the framework of the new EU Clinical Trials Regulation (536/2014/EU) by allowing researchers to share their experiences and solutions to any issue related to the future implementation of the new Regulation. One of the ideas from this platform is to create a 'Clinical Trials Facilitation Tool-kit' to support European Clinical Trials Groups in their set-up of international clinical trials for children and young people with cancer. The tool-kit will include guidance documents (e.g. templates) and advice to address the challenges frequently encountered (such as practicalities and contracts) in the development of non-commercial clinical trials across multiple countries and sites, including the specific issues arising when trials are run in partnership with the pharmaceutical industry. In order to assess what would be of greatest benefit to the clinical trials community, a short questionnaire has been circulated by SIOPE early 2016 to the Chairs of the European Clinical Trial Groups, inquiring about their greatest needs for support and guidance when starting a new trial or managing an existing one. According to respondents, the most needed function of a Clinical Trials Facilitation Tool-kit would be a template for agreements between the sponsor/co-sponsor and the national coordinating centre, defining delegated duties and responsibilities (4,29 points in answers’ weighted average). Other useful functions of the tool-kit were considered as desirable (in order of importance): an overall guidance as concerns trial management and monitoring (including how to manage serious breaches in trial compliance); a general Clinical Trial Protocol Template (already available as an ENCCA deliverable at; as ewell as more specific guidance on the following aspects:
  • Clinical trial risk assessment (as defined in the new Regulation);
  • The use of the EU submission portal to obtain clinical trial approval (as defined in the new Regulation);
  • Good practice in trial progress and final reporting;
  • Pharmacovigilance;
  • Management and analysis of safety data (methods of analysis were already completed as an ENCCA deliverable, and could be made available upon request);
  • The designation of Investigational Medicinal Products (IMPs);
  • Management of substantial amendments, suspension of trial recruitment and implementation of urgent safety measures;
  • The constitution and responsibilities of a Data Monitoring Committee;
  • Feasibility assessments for site and investigator selection.
This has been the first step in the creation of a new and useful Platform for our members, towards the overall aim of enabling a more effective set up and delivery of clinical trials in the SIOPE network.