On 8 February 2010 a multidisciplinary workshop entitled “Towards a Better Future for Pharmacovigilance in Clinical Trials” was held at EORTC Headquarters in Brussels. This workshop was organized by the EORTC and ECRIN on behalf of the Roadmap Initiative for Clinical Research in Europe. The main goal of the Roadmap Initiative is to work towards suggestions for improvements in potential legislation with the aim of facilitating the performance of clinical research for the benefit of patients and to increase the competitiveness of clinical research on the European level. This event was financially supported by the European Commission through the FP7 program (ECRIN – PPI).
Currently, Directive 2001/20/EC on clinical trials requires that each suspected unexpected serious adverse reaction (SUSAR) must be reported to the EMA, the competent authorities, and the relevant ethics committees (EC) of countries participating in the study by the deadlines set by the Directive. In addition, SUSARs must also be reported to all investigators. The purpose of the SUSAR is to point out unexpected trends during the period between Annual Safety Reports. However, the process for SUSAR notification as well as the parties to be addressed varies from country to country, and this process becomes particularly complex in international or even intercontinental clinical trial settings.
The current reporting requirements represent a significant and counterproductive amount of work for the sponsors, the competent authorities, ethics committees and investigators. They create a huge administrative burden, add no value to the information created in a clinical trial, and have not been shown to improve patient safety. This multidisciplinary workshop, therefore, explored the experiences of clinical research stakeholders with respect to pharmacovigilance management in clinical trials and examined proposals for a more appropriate pharmacovigilance reporting process in Europe.
Eighty two delegates from 15 European countries participated in the workshop, and all stakeholders were represented: academic clinical researchers, industry, ethics committees, patients, national competent authorities, and the European Medicines Agency. The workshop report can be found here.
The ultimate goal of the workshop was to provide a platform of recommendations, acceptable by all stakeholders. These recommendations would then be discussed and released during the final Stakeholder Conference to be held in Brussels on 17 March 2010, and final recommendations resulting from this conference would be submitted to the European Commission requesting initiation of the necessary legal steps to create an efficient pharmacovigilance process for clinical trials in Europe.
Stéphane Lejeune, Nathalie Dubois, Ingrid Klingmann and John Bean