Dataset Information

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.

ABSTRACT:

Background

'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries.

Methods

The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK).

Results

European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount.

Conclusions

'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.

SUBMITTER: Whitfield K

PROVIDER: S-EPMC2997627 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.

Whitfield Kate K Huemer Karl-Heinz KH Winter Diana D Thirstrup Steffen S Libersa Christian C Barraud Béatrice B Kubiak Christine C Stankovski Lea L Grählert Xina X Dreier Gabriele G Geismann Sebastian S Kuchinke Wolfgang W Strenge-Hesse Anke A Temesvari Zsuza Z Blasko Gyorgy G Kardos Gabriella G O'Brien Timothy T Cooney Margaret M Gaynor Siobhan S Schieppati Arrigo A Serrano Mariantonia M de Andres Fernando F Sanz Nuria N Hernández Raquel R Kreis Germán G Asker-Hagelberg Charlotte C Johansson Hanna H Asghar Adeeba A Husson Jean-Marc JM Demotes Jacques J Gluud Christian C

Trials 20101112

<h4>Background</h4>'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries.<h4>Methods</h4>The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, i ...[more]

PMID: 21073691

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Dataset Information

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.

Background

Methods

Results

Conclusions

Publications

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.

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