Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries. - Archive ouverte HAL Access content directly
Journal Articles Trials Year : 2010

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

(1) , (2) , (3) , (4) , (5) , (6) , (7) , (7) , (8) , (9) , (9) , (10) , (11) , (12) , (13) , (13) , (14) , (14) , (14) , (15) , (16) , (16) , (17) , (17) , (17) , (18) , (18) , (19) , (20) , (7) , (1)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Diana Winter
  • Function : Author
  • PersonId : 918840
Steffen Thirstrup
  • Function : Author
  • PersonId : 918421
Christian Libersa
  • Function : Author
  • PersonId : 918423
Christine Kubiak
  • Function : Author
  • PersonId : 918417
Lea Stankovski
  • Function : Author
  • PersonId : 918842
Xina Grählert
  • Function : Author
  • PersonId : 918425
Gabriele Dreier
  • Function : Author
  • PersonId : 918426
Sebastian Geismann
  • Function : Author
  • PersonId : 918843
Wolfgang Kuchinke
  • Function : Author
  • PersonId : 918419
Gyorgy Blasko
  • Function : Author
  • PersonId : 918429
Gabriella Kardos
  • Function : Author
  • PersonId : 918430
Timothy O'Brien
  • Function : Author
  • PersonId : 918431
Margaret Cooney
  • Function : Author
  • PersonId : 918845
Siobhan Gaynor
  • Function : Author
  • PersonId : 918433
Arrigo Schieppati
  • Function : Author
  • PersonId : 918434
Hanna Johansson
  • Function : Author
  • PersonId : 918438
Jean-Marc Husson
  • Function : Author
  • PersonId : 918442
Jacques Demotes
  • Function : Author
  • PersonId : 915136
Christian Gluud
  • Function : Author
  • PersonId : 902746

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.
Fichier principal
Vignette du fichier
1745-6215-11-104.pdf (227.37 Ko) Télécharger le fichier
Vignette du fichier
1745-6215-11-104-S1.PDF (76.55 Ko) Télécharger le fichier
Vignette du fichier
1745-6215-11-104.xml (59.46 Ko) Télécharger le fichier
Origin : Publisher files allowed on an open archive
Format : Other
Format : Other

Dates and versions

inserm-00663712 , version 1 (27-01-2012)

Identifiers

Cite

Kate Whitfield, Karl-Heinz Huemer, Diana Winter, Steffen Thirstrup, Christian Libersa, et al.. Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.. Trials, 2010, 11 (1), pp.104. ⟨10.1186/1745-6215-11-104⟩. ⟨inserm-00663712⟩

Collections

INSERM
426 View
1117 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More