Clinical research is a very important and mandatory step in the process of developing new medicines. It is necessary to obtain data regarding the effectiveness and safety of these medicines. A harmonised approach ensures unified principles in the evaluation of applications for clinical trials throughout Europe and a competent benefit/risk assessment.
In comparison to the Directive 2001/20/EC currently in effect, the Regulation will ensure that there will be a lot more publicly available information regarding clinical trials, this will include an obligation for sponsors to publish all clinical trial results. The results will be published even if they are not positive. The Regulation also stipulates that all clinical trial applications will be submitted into one single Portal, which will be a new European Clinical Trial Database, thus, ensuring the availability of information for all residents.
Meeting participants (clinical trial experts from national medicines agencies in Europe and from the European Medicines Agency) also discussed the following topics related to the Regulation:
- Progress in the preparation of national normative acts in EU Member States.
- Voluntary harmonisation procedure streamlining in order to ensure a coordinated and rational evaluation of multinational clinical trial applications. Voluntary harmonisation procedure is an introduction and implementation of principles of a certain work model/introductory regulation.
- Determination of criteria for the assignment of a reference Member State in the process of clinical trial evaluation and coordination of this process in the EU Portal.
- Modifying the operation of national ethics committees for the effective implementation of the requirements of the Regulation.
- Ensuring circulation of safety information, including annual safety reports, in the common Portal and its harmonised assessment.
- Streamlining the format of the prepared clinical trial application assessment report and its implementation.
- Issues related to the assessment of clinical trial applications (criteria for compliance evaluation of diagnostic tests, discussions about the progress of ongoing clinical trials in the EU in relation to inconclusive data in the positive benefit/risk ratio).
The Heads of Medicines Agencies (HMA) agreed in 2004 to establish the Clinical Trials Facilitation Group (CTFG) to coordinate the implementation of the European Clinical Trials Directive 2001/20 EC across the Member States. Future CTFG activities are related to the establishment of unified principles and procedures for the evaluation and authorisation of clinical trials throughout Europe. Additional information regarding the Clinical Trials Facilitation Group is available on HMA website.