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

Autor: Gabriella Kardos, Xina Grählert, Margaret Cooney, Raquel Hernandez, György Blaskó, Anke Strenge-Hesse, Mariantonia Serrano, Wolfgang Kuchinke, Timothy O'Brien, Christine Kubiak, Fernando de Andres, Arrigo Schieppati, Christian Gluud, Jacques Demotes, Jean-Marc Husson, Hanna Johansson, Diana Winter, Siobhan Gaynor, Nuria Sanz, Steffen Thirstrup, Béatrice Barraud, German Kreis, Sebastian Geismann, Kate Whitfield, Charlotte Asker-Hagelberg, Lea Stankovski, Christian Libersa, Gabriele Dreier, Adeeba Asghar, Zsuza Temesvari, Karl-Heinz Huemer
Přispěvatelé: BMC, Ed., Copenhagen Trial Unit (CTU), Copenhagen University Hospital (DCRIN), Koordinierungszentrum für klinische Studien MUW, ATCRIN, The Danish Medicines Agency, CIC CHU ( Lille)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Institut National de la Santé et de la Recherche Médicale (Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM), ECRIN Coordination Office, Coordinating Centre for Clinical Trials, Medical Faculty - Carl Gustav Carus, ZKS - Clinical Trials Center, University Medical Centre Freiburg, Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Network of Coordinating Centres for Clinical Trials (KKS Network), University of Cologne, Ministry of Health Social and Family Affairs, Medical Research Council, Ministry of Health, Medical Research Council-Hungarian ECRIN Committee (HECRIN), Molecular Medicine Ireland (MMI), Irish Clinical Research Infrastructure Network (ICRIN)-National University of Ireland [Galway] (NUI Galway), Farmacologiche Mario Negri (IRFMN), Instituto Superiore di Sanita (ISS), Spanish Medicines Agency and Medical Devices (AEMPS), Spanish Medicines Agency and Medical Devices [Madrid] (AEMPS), Hospital Clinic i Provincial de Barcelona (SCReN), Karolinska University Hospital (SweCRIN), NIHR Clinical Research Network Coordination Centre, European Forum for Good Clinical Practice
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Compassionate Use Trials
medicine.medical_specialty
Biomedical Research
MESH: Clinical Trials as Topic
Alternative medicine
MEDLINE
Psychological intervention
Medicine (miscellaneous)
Severe disease
Klinikai orvostudományok
03 medical and health sciences
0302 clinical medicine
Nursing
European Clinical Research Infrastructures Network (ECRIN)
medicine
Humans
media_common.cataloged_instance
Pharmacology (medical)
030212 general & internal medicine
European union
030304 developmental biology
media_common
Clinical Trials as Topic
lcsh:R5-920
0303 health sciences
MESH: Humans
business.industry
MESH: Compassionate Use Trials
Research
MESH: Biomedical Research
compassionate use programmes
Compassionate Use
Orvostudományok
European Regulation 726/2004/EC
humanities
3. Good health
Europe
Clinical research
[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
MESH: Europe
lcsh:Medicine (General)
business
expanded access programmes
Zdroj: Trials
Trials, BioMed Central, 2010, 11 (1), pp.104. ⟨10.1186/1745-6215-11-104⟩
Trials, Vol 11, Iss 1, p 104 (2010)
ISSN: 1745-6215
DOI: 10.1186/1745-6215-11-104⟩
Popis: 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.
Databáze: OpenAIRE
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