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

Trials

Volumn 11, Issue , 2010, Pages

  Whitfield, Kate ^a   Huemer, Karl Heinz ^b   Winter, Diana ^c   Thirstrup, Steffen ^d   Libersa, Christian ^e   Barraud, Béatrice ^e   Kubiak, Christine ^e   Stankovski, Lea ^e   Grählert, Xina ^f   Dreier, Gabriele ^g   Geismann, Sebastian ^g   Kuchinke, Wolfgang ^h   Strenge Hesse, Anke ⁱ   Temesvari, Zsuza ^j   Blasko, Gyorgy ^k   Kardos, Gabriella ^k   O'Brien, Timothy ^l   Cooney, Margaret ^l   Gaynor, Siobhan ^l   Schieppati, Arrigo ^m   Serrano, Mariantonia ⁿ   de Andres, Fernando ⁿ   Sanz, Nuria ^o   Hernández, Raquel ^o   Kreis, Germán ^o   Asker Hagelberg, Charlotte ^p   Johansson, Hanna ^p   Asghar, Adeeba ^q   Husson, Jean Marc ^r   Demotes, Jacques ^e   Gluud, Christian ^a   more..

^a Mental Health Services CPH   (Denmark)

^b Koordinierungszentrum für klinische Studien MUW ^*  (Austria)

^c ATCRIN   (Austria)

^d DANISH MEDICINES AGENCY   (Denmark)

^e INSERM   (France)

^f DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^g UNIVERSITY OF FREIBURG   (Germany)

^h HEINRICH HEINE UNIVERSITY   (Germany)

ⁱ UNIVERSITY OF COLOGNE   (Germany)

^j Medical Research Council   (Hungary)

^k Ministry of Health   (Hungary)

^l NATIONAL UNIVERSITY OF IRELAND   (Ireland)

^m MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

ⁿ Parque Empresarial Las Mercedes   (Spain)

^o HOSPITAL CLÍNIC   (Spain)

^p KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^q NIHR Clinical Research Network Coordinating Centre   (United Kingdom)

^r European Forum for Good Clinical Practice   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; HEALTH PROGRAM; HEALTH SURVEY; LAW; CLINICAL TRIAL (TOPIC); COMPASSIONATE USE; EUROPE; HUMAN; LEGAL ASPECT; MEDICAL RESEARCH;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; COMPASSIONATE USE TRIALS; EUROPE; HUMANS;

EID: 78149321352     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-11-104     Document Type: Article

References (27)

1. European Parliament and the Council of the European Union Regulation 726/2004/EC of the European Parliament and of the Council of 31 March 2004. Official Journal of the European Union 2004, European Parliament and the Council of the European Union., http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF
2. Committee for medicinal products for human use, European Medicines Agency Guideline on compassionate use of medicinal products. 2007, Committee for medicinal products for human use, European Medicines Agency., http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004075.pdf
3. Conditions for use, conditions for distribution and patients targeted and conditions for safety monitoring addressed to member states for TAMIFLU IV available for compassionate use. EMA/45566/2010. , http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/01/WC500069899.pdf
4. Summary on compassionate use for TAMIFLU IV. EMA/138749/2010. , http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/05/WC500090250.pdf
5. European Medicines Agency - Compassionate Use. , http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000293.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058007e691&jsenabled=true
6. Kubiak C, de Andres F, Kuchinke W, Huemer KH, Whitfield K, Barraud B, Grählert X, Dreier G, Grychtol R, Temesvari Z, et al. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials 2009, 10:95. 10.1186/1745-6215-10-95, 2768680, 19835581.
7. Austrian Drug Act. Österreichisches Arzneimittelgesetz BGBl. I Nr. 185/1983. , http://faolex.fao.org/docs/pdf/aut33130.pdf
8. Danish Medicines Agency. , http://www.dkma.dk/1024/visUKLSForside.asp?artikelID=728
9. Legifrance - Code de la santé publique, article L5121-12. , http://www.legifrance.gouv.fr/affichCodeArticle.do?idArticle=LEGIARTI000006689903&cidTexte=LEGITEXT000006072665&dateTexte=20091022&oldAction=rechCodeArticle
10. Agence française de sécurité sanitaire des produits de santé (afssaps): Notice to applicants for temporary authorisation for use (ATU). , http://www.afssaps.fr/var/afssaps_site/storage/original/application/32f7b4f77a894fa586797500dd52063c.pdf
11. German medicines act. , http://bundesrecht.juris.de/bundesrecht/amg_1976/gesamt.pdf
12. BfArM - Arzneimittel-Härtefallprogramme/Compassionate Use. , http://www.bfarm.de/cln_103/DE/Home/home_node.html
13. Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540 of 2007). , http://www.dohc.ie/legislation/statutory_instruments/pdf/si20070540.pdf?direct=1
14. Irish Medicines Board - Notification System for Exempt (Unauthorised). Products. , http://www.imb.ie/EN/Medicines/Human-Medicines/Notification-System-for-Exempt-Unauthorised-Products.aspx?categorypageid=0&categorytypeid=-1
15. Gazzetta ufficiale nr 17.3. , http://gazzette.comune.jesi.an.it/2003/173/gazzetta173.htm
16. Gazzetta ufficiale nr 153. , http://gazzette.comune.jesi.an.it/2006/142/
17. Spanish Royal Decree 223/2004 on clinical trials with medicinal products. , http://www.boe.es/boe/dias/2004/02/07/pdfs/A05429-05443.pdf
18. MHRA - Medicines that do not need a licence (Exemptions from licensing). , http://www.mhra.gov.uk/Howweregulate/Medicines/Doesmyproductneedalicence/Medicinesthatdonotneedalicence/CON009278
19. MHRA - The supply of unlicensed relevant medicinal products for individual patients, MHRA Guidance Note No.14. 2008. , http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con007547.pdf
20. Brierley J, Larcher V. Compassionate and innovative treatments in children: a proposal for an ethical framework. Archives of Disease in Childhood 2009, 94:651-654. 10.1136/adc.2008.155317, 19457880.
21. Kent and Medway Area Prescribing Committee (K&M APC) - Access to unlicensed investigational drugs outside of clinical trials via expanded access or compassionate use programmes. , http://www.kentandmedway.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=16089
22. US Food and Drug Administration - Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs. , http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
23. Swiss Medic - Pharmacolvigilance. , http://www.swissmedic.ch/marktueberwachung/00091/00136/00137/index.html?lang=en
24. Swiss Medic - Legislation governing therapeutic products in Switzerland. , http://www.swissmedic.ch/rechtstexte/00201/00203/index.html?lang=en
25. Okie S. Access before approval-a right to take experimental drugs?. New Engl J Med 2006, 355:437-440. 10.1056/NEJMp068132, 16885545.
26. Ross E. Unapproved drug use: compassionate or cause for concern?. The Lancet Neurol 2009, 8:136-137.
27. The Declaration of Helsinki. Ethical principles for medical research involving human subjects. , http://www.wma.net/en/30publications/10policies/b3/index.html