메뉴 건너뛰기




Volumn 36, Issue 6, 2010, Pages 322-325

'(More) trials and tribulations': The effect of the EU directive on clinical trials in intensive care and emergency medicine, five years after its implementation

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; EMERGENCY MEDICINE; ETHICS; EUROPE; EUROPEAN UNION; HUMAN; INFORMED CONSENT; INTENSIVE CARE; LEGAL ASPECT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD;

EID: 77956083217     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2009.035261     Document Type: Article
Times cited : (13)

References (38)
  • 1
    • 33644899089 scopus 로고    scopus 로고
    • Harmful impact of EU Clinical Trials Directive
    • Hemminki A. Harmful impact of EU Clinical Trials Directive. Br Med J 2006;332:501-2.
    • (2006) Br Med J , vol.332 , pp. 501-502
    • Hemminki, A.1
  • 2
    • 49249094300 scopus 로고    scopus 로고
    • Conducting a European multi-centre trial: first experiences with the new European Clinical Trials Directive from an academic perspective
    • Delawi D, Dhert WJA, Oner FC. Conducting a European multi-centre trial: first experiences with the new European Clinical Trials Directive from an academic perspective. Eur Spine J 2008;17:1113-15.
    • (2008) Eur Spine J , vol.17 , pp. 1113-1115
    • Delawi, D.1    Dhert, W.J.A.2    Oner, F.C.3
  • 3
    • 33846020021 scopus 로고    scopus 로고
    • The impact of the 'clinical trials' directive on the cost and conduct of non-commercial cancer trials in the UK
    • Hearn J, Sullivan R. The impact of the 'clinical trials' directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer 2007;43:8-13.
    • (2007) Eur J Cancer , vol.43 , pp. 8-13
    • Hearn, J.1    Sullivan, R.2
  • 4
    • 77956092706 scopus 로고    scopus 로고
    • Impact on Clinical Research of European Legislation (ICREL) project final report. February
    • Impact on Clinical Research of European Legislation (ICREL) project final report. February 2009. http://www.efgcp.be/Downloads/EFGCP%20Annual% 20Report%20of%20Activities%202009.pdf.
    • (2009)
  • 5
    • 0003177157 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and Council of 4th April 2001
    • European Parliament
    • European Parliament. Directive 2001/20/EC of the European Parliament and Council of 4th April 2001. Official Journal of the European Communities 2001;121:34-44.
    • (2001) Official Journal of the European Communities , vol.121 , pp. 34-44
  • 6
    • 77956068285 scopus 로고    scopus 로고
    • Law of 7 May 2004 concerning experiments on the human person: Loi relative aux Expérimentations sur la Personne Humaine (LEH)
    • Law of 7 May 2004 concerning experiments on the human person: Loi relative aux Expérimentations sur la Personne Humaine (LEH). http://www.fagg-afmps.be/en/binaries/law-2004-05-07_tcm292-27420.doc.
  • 7
    • 77956076881 scopus 로고    scopus 로고
    • 154th Act of 1997 on health-care: 1997. évi CLIV. törvény az egészségügyro{double acute}
    • 154th Act of 1997 on health-care: 1997. évi CLIV. törvény az egészségügyro{double acute}.
  • 8
    • 77956079809 scopus 로고    scopus 로고
    • Research Involving Human Subjects Act (WMO)
    • Research Involving Human Subjects Act (WMO) 1998. http://www.healthlaw.nl/humsub.pdf.
    • (1998)
  • 9
    • 77956066254 scopus 로고    scopus 로고
    • Health Research Act: Act 20-06-2008 No. 44
    • Health Research Act: Act 20-06-2008 No. 44.
  • 10
    • 77956084448 scopus 로고    scopus 로고
    • Royal Decree 223/2004 of 6 February, on clinical trials involving medicinal products: Real Decreto 223/2004, de 6 de febrero, por el que se regulan los ensayos clínicos con medicamentos
    • Royal Decree 223/2004 of 6 February, on clinical trials involving medicinal products: Real Decreto 223/2004, de 6 de febrero, por el que se regulan los ensayos clínicos con medicamentos. http://www.eurecnet.org/information/spain.html.
  • 11
    • 77949482007 scopus 로고    scopus 로고
    • Nonurgent patients in the emergency department? A French formula to prevent misuse
    • Stéphanie Gentile, Pascal Vignally, Anne-Claire Durand, et al. Nonurgent patients in the emergency department? A French formula to prevent misuse. BMC Health Services Research 2010;10:66.
    • (2010) BMC Health Services Research , vol.10 , pp. 66
    • Gentile, S.1    Pascal, V.2    Durand, A.-C.3
  • 12
    • 77956092394 scopus 로고    scopus 로고
    • Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460; updated in SFS 2008:192)
    • Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460; updated in SFS 2008:192).
  • 13
    • 77949504169 scopus 로고    scopus 로고
    • The European Communities (Clinical Trials on Medicinal Products for Human Use)
    • The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.
    • (2004) Regulations
  • 14
    • 77956093691 scopus 로고    scopus 로고
    • The Medical Research Act 488/1999 (amended by 295/2004)
    • The Medical Research Act 488/1999 (amended by 295/2004)
  • 15
    • 77956076455 scopus 로고    scopus 로고
    • Adults With Incapacity (Scotland) Act
    • Adults With Incapacity (Scotland) Act 2004
    • (2004)
  • 16
    • 77956084007 scopus 로고    scopus 로고
    • The Mental Capacity Act
    • The Mental Capacity Act 2005
    • (2005)
  • 17
    • 77956093262 scopus 로고    scopus 로고
    • The Medicines Act (Arneimittelgesetz) of 1983, last amended in 2008 (BGBI. I Nr. 115/2008)
    • The Medicines Act (Arneimittelgesetz) of 1983, last amended in 2008 (BGBI. I Nr. 115/2008).
  • 18
    • 77956077359 scopus 로고    scopus 로고
    • The German Drug Act (Arzneimittelgesetz; AMG)
    • The German Drug Act (Arzneimittelgesetz; AMG).
  • 19
    • 77956079062 scopus 로고    scopus 로고
    • Legislative decree no. 211 of June 24 2003
    • Legislative decree no. 211 of June 24 2003.
  • 21
    • 77956073977 scopus 로고    scopus 로고
    • The EFGCP Report on the Procedure for Ethical Review of Protocols for Clinical Research Projects in the European Union. November 2006
    • The EFGCP Report on the Procedure for Ethical Review of Protocols for Clinical Research Projects in the European Union. November 2006. http://www.efgcp.be/Downloads/EFGCPReportFiles/Italy%202010.pdf.
  • 22
    • 77956088771 scopus 로고    scopus 로고
    • The Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects no. 402 of 28 May 2003 (amended in Act No. 272 1 of April 2006)
    • The Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects no. 402 of 28 May 2003 (amended in Act No. 272 1 of April 2006).
  • 23
    • 10744230615 scopus 로고    scopus 로고
    • The European directive: a further blow to intensive care medicine in Austria
    • Druml C, Singer EA. The European directive: a further blow to intensive care medicine in Austria. Intensive Care Med 2004;30:335.
    • (2004) Intensive Care Med , vol.30 , pp. 335
    • Druml, C.1    Singer, E.A.2
  • 24
    • 0036272427 scopus 로고    scopus 로고
    • A serious threat to evidence based resuscitation within the European Union
    • Sterz F, A Singer E, Böttiger B, et al. A serious threat to evidence based resuscitation within the European Union. Resuscitation 2002;53:237-8.
    • (2002) Resuscitation , vol.53 , pp. 237-238
    • Sterz, F.1    Singer, A.2    Böttiger, B.3
  • 25
    • 18744409613 scopus 로고    scopus 로고
    • The European directive on clinical research: present status of implementation in EU member states' legislations with regard to the incompetent patient
    • Lemaire F, Bion J, Blanco J, et al. The European directive on clinical research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med 2005;31:476-9.
    • (2005) Intensive Care Med , vol.31 , pp. 476-479
    • Lemaire, F.1    Bion, J.2    Blanco, J.3
  • 26
    • 33645839880 scopus 로고    scopus 로고
    • The European Clinical Trials Directive revisited: the VISEAR recommendations
    • Liddell K, Chamberlain D, Menon DK, et al. The European Clinical Trials Directive revisited: the VISEAR recommendations. Resuscitation 2006;69:9-14.
    • (2006) Resuscitation , vol.69 , pp. 9-14
    • Liddell, K.1    Chamberlain, D.2    Menon, D.K.3
  • 27
    • 34748863659 scopus 로고    scopus 로고
    • Evaluating benefits and harms in intensive care research
    • Weijer C, Miller PB. Evaluating benefits and harms in intensive care research. Intensive Care Med 2007;33:1819-22.
    • (2007) Intensive Care Med , vol.33 , pp. 1819-1822
    • Weijer, C.1    Miller, P.B.2
  • 28
    • 62949122351 scopus 로고    scopus 로고
    • Protocols in expedited review: tackling the workload of ethics committees
    • Woltz M, Druml C, Leitner D, et al. Protocols in expedited review: tackling the workload of ethics committees. Intensive Care Med 2009;35:613-15.
    • (2009) Intensive Care Med , vol.35 , pp. 613-615
    • Woltz, M.1    Druml, C.2    Leitner, D.3
  • 29
    • 4344714862 scopus 로고    scopus 로고
    • Breast cancer research and the European union Clinical Trials Directive
    • Williams N. Breast cancer research and the European union Clinical Trials Directive. Breast Cancer Res 2004;6:145-7.
    • (2004) Breast Cancer Res , vol.6 , pp. 145-147
    • Williams, N.1
  • 30
    • 77956076285 scopus 로고    scopus 로고
    • The European Science Foundation. March
    • The European Science Foundation. Forward Look: Investigator-driven clinical trials. March 2009. http://www.esf.org/activities/forward-looks/medical-sciencesemrc/fl-07-001-investigator-driven-clinical-trials.html.
    • (2009) Forward Look: Investigator-driven clinical trials
  • 31
    • 14944375041 scopus 로고    scopus 로고
    • Collateral damage or apocalypse now for European academic research
    • Singer EA, Druml C. Collateral damage or apocalypse now for European academic research. Intensive Care Med 2005 31:271.
    • (2005) Intensive Care Med , vol.31 , pp. 271
    • Singer, E.A.1    Druml, C.2
  • 32
    • 10244255015 scopus 로고    scopus 로고
    • Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive
    • Druml C. Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive. Curr Opin Crit Care 2004;10:570-3.
    • (2004) Curr Opin Crit Care , vol.10 , pp. 570-573
    • Druml, C.1
  • 33
    • 33750529955 scopus 로고    scopus 로고
    • Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC
    • Liddel K, Bion J, Chamberlain D, et al. Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC. Med Law Rev 2006;14:367-417.
    • (2006) Med Law Rev , vol.14 , pp. 367-417
    • Liddel, K.1    Bion, J.2    Chamberlain, D.3
  • 36
    • 38149018609 scopus 로고    scopus 로고
    • Effect of the European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006
    • Berendt L, Håkansson C, Bach KF, et al. Effect of the European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006. Br Med J 2008 336:33-5.
    • (2008) Br Med J , vol.336 , pp. 33-35
    • Berendt, L.1    Håkansson, C.2    Bach, K.F.3
  • 37
    • 34250362785 scopus 로고    scopus 로고
    • The EU Clinical Trials Directive: 3 years on
    • Hoey R. The EU Clinical Trials Directive: 3 years on. Lancet 2007;369:1777-8.
    • (2007) Lancet , vol.369 , pp. 1777-1778
    • Hoey, R.1
  • 38
    • 77956093420 scopus 로고    scopus 로고
    • Medical Research Council Clinical Trials toolkit
    • Medical Research Council Clinical Trials toolkit. http://www.ct-toolkit.ac.uk


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.