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001-es BibID:	BIBFORM036729
035-os BibID:	PMID:19835581
Első szerző:	Kubiak, Christine
Cím:	Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN) / Christine Kubiak, Fernando de Andres-Trelles, Wolfgang Kuchinke, Karl-Heinz Huemer, Steffen Thirstrup, Kate Whitfield, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Ruth Grychtol, Zsuzsa Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Nuria Sanz, Raquel Hernandez, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Jane Byrne, Adeeba Asghar, Jean-Marc Husson, Christian Gluud, Jacques Demotes-Mainard
Dátum:	2009
ISSN:	1745-6215
Megjegyzések:	BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. CONCLUSION: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban külföldön készült közlemény
Megjelenés:	Trials (electronic resources). - 10 : 95 (2009), p. 1-7. -
További szerzők:	Andres-Trelles, Fernando de Kuchinke, Wolfgang Huemer, Karl-Heinz Thirstrup, Steffen Whitfield, Kate Libersa, Christian Barraud, Béatrice Grählert, Xina Dreier, Gabriele Grychtol, Ruth Temesvári Zsuzsa Kardos Gabriella O'Brien, Timothy Cooney, Margaret Gaynor, Siobhan Schieppati, Arrigo Sanz, Nuria Hernandez, Raquel Asker-Hagelberg, Charlotte Johansson, Hanna Bourne, Sue Byrne, Jane Asghar, Adeeba Husson, Jean-Marc Gluud, Christian Demotes-Mainard, Jacques Blaskó György (1947-) (belgyógyász, klinikai farmakológus)
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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001-es BibID:	BIBFORM037465
035-os BibID:	PMID:21073691
Első szerző:	Whitfield, Kate
Cím:	Compassionate use of interventions : results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries / Kate Whitfield, Karl-Heinz Huemer, Diana Winter, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Christine Kubiak, Lea Stankovski, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Anke Strenge-Hesse, Zsuzsa Temesvari, György Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Mariantonia Serrano, Fernando de Andres, Nuria Sanz, Raquel Hernández, Germán Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes, Christian Gluud
Dátum:	2010
ISSN:	1745-6215
Megjegyzések:	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.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban egyetemen (Magyarországon) készült közlemény
Megjelenés:	Trials. - 11 (2010), p. 104. -
További szerzők:	Huemer, Karl-Heinz Winter, Diana Thirstrup, Steffen Libersa, Christian Barraud, Béatrice Kubiak, Christine Stankovski, Lea Grählert, Xina Dreier, Gabriele Geismann, Sebastian Kuchinke, Wolfgang Strenge-Hesse, Anke Temesvári Zsuzsa Kardos Gabriella O'Brien, Timothy Cooney, Margaret Gaynor, Siobhan Schieppati, Arrigo Serrano, Mariantonia Andres-Trelles, Fernando de Sanz, Nuria Hernandez, Raquel Kreis, German Asker-Hagelberg, Charlotte Johansson, Hanna Asghar, Adeeba Husson, Jean-Marc Demotes-Mainard, Jacques Gluud, Christian Blaskó György (1947-) (belgyógyász, klinikai farmakológus)
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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