EFGCP Regional Conference on

Hot Topics in Clinical Research

15 & 16 October 2012 - Abba Garden Hotel, Barcelona, Spain

Jointly organised by EFGCP & Institut Borja de Bioètica, in partnership with Fundació Víctor Grífols i Lucas

Clinical trial processes and procedures are constantly changing due to the stakeholders’ attempt to improve the protection of patient rights, the reliability of study results and the efficiency of clinical study performance. Two areas are still considered as not achieving these objectives: the current informed consent process is not reliably enabling

study subjects to make a conscious decision on their participation and especially clinical research in emergency conditions is hampered by the different approaches in different EU Member States and the differences in clinical study practice; and despite all best harmonisation intentions the Clinical Trials Directive has led to a substantial increase in bureaucracy without increasing the number of clinical trials or the patient recruitment rates in Europe and therefore needs substantial revision. In July 2012 the European Commission’s DG SANCO has released a draft “REGULATION on clinical trials on medicinal products for human use repealing Directive 2001/20/EC” which now needs to be discussed in the European Parliament and Council of Europe. This regulation aims at streamlining the key processes, drastically reducing bureaucracy and shortening approval timelines. The regulation provides the frame, however, each Member State will have to work out how to fulfill the requirements, e.g. for the collaboration between competent authority and ethics committees in the approval assessment or the provision of a national indemnification mechanism.

This EFGCP Regional Conference will provide an opportunity to share experience and work out approaches to

provide more meaningful information to study participants in routine and emergency research. And it will invite to a

first discussion on the impact, current concerns and solution options of the future clinical trial legislation while there will also be a constructive debate on pragmatic approaches towards improvements within the current legislation in the next 2 to 4 years until the new legislation will come into force in all Member States.

A report will be written up for wider dissemination of the conference results.