Whitfield, Kate, Huemer, Karl-Heinz, Winter, Diana, Thirstrup, Steffen, Libersa, Christian, Barraud, Beatrice, Kubiak, Christine, Stankovski, Lea, Graehlert, Xina, Dreier, Gabriele, Geismann, Sebastian, Kuchinke, Wolfgang ORCID: 0000-0002-2809-6900, Strenge-Hesse, Anke, Temesvari, Zsuza, Blasko, Gyorgy, Kardos, Gabriella, O'Brien, Timothy ORCID: 0000-0001-9028-5481, Cooney, Margaret, Gaynor, Siobhan, Schieppati, Arrigo, Serrano, Mariantonia, de Andres, Fernando, Sanz, Nuria, Hernandez, Raquel, Kreis, German, Asker-Hagelberg, Charlotte, Johansson, Hanna, Asghar, Adeeba, Husson, Jean-Marc, Demotes, Jacques and Gluud, Christian ORCID: 0000-0002-8861-0799 (2010). Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries. Trials, 11. LONDON: BIOMED CENTRAL LTD. ISSN 1745-6215

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Whitfield, KateUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huemer, Karl-HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Winter, DianaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thirstrup, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Libersa, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barraud, BeatriceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kubiak, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stankovski, LeaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graehlert, XinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreier, GabrieleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geismann, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuchinke, WolfgangUNSPECIFIEDorcid.org/0000-0002-2809-6900UNSPECIFIED
Strenge-Hesse, AnkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Temesvari, ZsuzaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blasko, GyorgyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kardos, GabriellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
O'Brien, TimothyUNSPECIFIEDorcid.org/0000-0001-9028-5481UNSPECIFIED
Cooney, MargaretUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaynor, SiobhanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schieppati, ArrigoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Serrano, MariantoniaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Andres, FernandoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sanz, NuriaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hernandez, RaquelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreis, GermanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asker-Hagelberg, CharlotteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Johansson, HannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asghar, AdeebaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Husson, Jean-MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Demotes, JacquesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gluud, ChristianUNSPECIFIEDorcid.org/0000-0002-8861-0799UNSPECIFIED
URN: urn:nbn:de:hbz:38-492538
DOI: 10.1186/1745-6215-11-104
Journal or Publication Title: Trials
Volume: 11
Date: 2010
Publisher: BIOMED CENTRAL LTD
Place of Publication: LONDON
ISSN: 1745-6215
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
Medicine, Research & ExperimentalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/49253

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