Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries
<p>Abstract</p> <p>Background</p> <p>'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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2010-11-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/11/1/104 |
| _version_ | 1811329270738321408 |
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| author | de Andres Fernando Serrano Mariantonia Schieppati Arrigo Gaynor Siobhan Cooney Margaret O'Brien Timothy Kardos Gabriella Blasko Gyorgy Temesvari Zsuza Strenge-Hesse Anke Kuchinke Wolfgang Geismann Sebastian Dreier Gabriele Grählert Xina Stankovski Lea Kubiak Christine Barraud Béatrice Libersa Christian Thirstrup Steffen Winter Diana Huemer Karl-Heinz Whitfield Kate Sanz Nuria Hernández Raquel Kreis Germán Asker-Hagelberg Charlotte Johansson Hanna Asghar Adeeba Husson Jean-Marc Demotes Jacques Gluud Christian |
| author_facet | de Andres Fernando Serrano Mariantonia Schieppati Arrigo Gaynor Siobhan Cooney Margaret O'Brien Timothy Kardos Gabriella Blasko Gyorgy Temesvari Zsuza Strenge-Hesse Anke Kuchinke Wolfgang Geismann Sebastian Dreier Gabriele Grählert Xina Stankovski Lea Kubiak Christine Barraud Béatrice Libersa Christian Thirstrup Steffen Winter Diana Huemer Karl-Heinz Whitfield Kate Sanz Nuria Hernández Raquel Kreis Germán Asker-Hagelberg Charlotte Johansson Hanna Asghar Adeeba Husson Jean-Marc Demotes Jacques Gluud Christian |
| author_sort | de Andres Fernando |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>'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.</p> <p>Methods</p> <p>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).</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>'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.</p> |
| first_indexed | 2024-04-13T15:40:50Z |
| format | Article |
| id | doaj.art-80d54c88429e4912aecac085f614a10b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T15:40:50Z |
| publishDate | 2010-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-80d54c88429e4912aecac085f614a10b2022-12-22T02:41:09ZengBMCTrials1745-62152010-11-0111110410.1186/1745-6215-11-104Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countriesde Andres FernandoSerrano MariantoniaSchieppati ArrigoGaynor SiobhanCooney MargaretO'Brien TimothyKardos GabriellaBlasko GyorgyTemesvari ZsuzaStrenge-Hesse AnkeKuchinke WolfgangGeismann SebastianDreier GabrieleGrählert XinaStankovski LeaKubiak ChristineBarraud BéatriceLibersa ChristianThirstrup SteffenWinter DianaHuemer Karl-HeinzWhitfield KateSanz NuriaHernández RaquelKreis GermánAsker-Hagelberg CharlotteJohansson HannaAsghar AdeebaHusson Jean-MarcDemotes JacquesGluud Christian<p>Abstract</p> <p>Background</p> <p>'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.</p> <p>Methods</p> <p>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).</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>'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.</p>http://www.trialsjournal.com/content/11/1/104 |
| spellingShingle | de Andres Fernando Serrano Mariantonia Schieppati Arrigo Gaynor Siobhan Cooney Margaret O'Brien Timothy Kardos Gabriella Blasko Gyorgy Temesvari Zsuza Strenge-Hesse Anke Kuchinke Wolfgang Geismann Sebastian Dreier Gabriele Grählert Xina Stankovski Lea Kubiak Christine Barraud Béatrice Libersa Christian Thirstrup Steffen Winter Diana Huemer Karl-Heinz Whitfield Kate Sanz Nuria Hernández Raquel Kreis Germán Asker-Hagelberg Charlotte Johansson Hanna Asghar Adeeba Husson Jean-Marc Demotes Jacques Gluud Christian Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries Trials |
| title | Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries |
| title_full | Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries |
| title_fullStr | Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries |
| title_full_unstemmed | Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries |
| title_short | Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries |
| title_sort | compassionate use of interventions results of a european clinical research infrastructures network ecrin survey of ten european countries |
| url | http://www.trialsjournal.com/content/11/1/104 |
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