-
1
-
-
60849106348
-
Ethical and scientific implications of the globalization of clinical research
-
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009, 360:816-823.
-
(2009)
N Engl J Med
, vol.360
, pp. 816-823
-
-
Glickman, S.W.1
McHutchison, J.G.2
Peterson, E.D.3
Cairns, C.B.4
Harrington, R.A.5
Califf, R.M.6
Schulman, K.A.7
-
3
-
-
0003177157
-
Directive 2001/20/EC of the European Parliament and the Council of 4 Apr 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
-
Directive 2001/20/EC of the European Parliament and the Council of 4 Apr 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Community 2001, L121:34-44.
-
(2001)
Official J Eur Community
, vol.L121
, pp. 34-44
-
-
-
4
-
-
77951705293
-
Has the European Clinical Trials Directive been a success?
-
Frewer LJ, Coles D, Champion K, Demotes-Mainard J, Goetbuget N, Ihrig K, Klingmann I, Kubiak C, Lejeune SA, McDonald F, Apperley J. Has the European Clinical Trials Directive been a success?. BMJ 2010, 340:937.
-
(2010)
BMJ
, vol.340
, pp. 937
-
-
Frewer, L.J.1
Coles, D.2
Champion, K.3
Demotes-Mainard, J.4
Goetbuget, N.5
Ihrig, K.6
Klingmann, I.7
Kubiak, C.8
Lejeune, S.A.9
McDonald, F.10
Apperley, J.11
-
5
-
-
84860886622
-
Report on the Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future
-
European Commission - European Medicines Agency
-
European Commission - European Medicines Agency Report on the Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future. European Commission - European Medicines Agency., http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500011204.pdf
-
-
-
-
6
-
-
84859933378
-
Impact on Clinical Research of European Legislation (ICREL): Project Final Report
-
Klingmann I. Impact on Clinical Research of European Legislation (ICREL): Project Final Report. , http://www.efgcp.be/downloads/icrel_docs/Final_report_ICREL.pdf
-
-
-
Klingmann, I.1
-
7
-
-
68149102900
-
Investigator-Driven Clinical Trials
-
European Science Foundation-EMRC - Forward Look
-
European Science Foundation-EMRC - Forward Look Investigator-Driven Clinical Trials. European Science Foundation-EMRC - Forward Look., http://www.esf.org/fileadmin/links/EMRC/FL_IDCT.pdf
-
-
-
-
8
-
-
84860886707
-
Assessment of the functioning of the 'Clinical Trials Directive 2001/20/EC
-
European Commission
-
European Commission Assessment of the functioning of the 'Clinical Trials Directive 2001/20/EC. European Commission., http://ec.europa.eu/health/files/clinicaltrials/docs/2009_10_09_public-consultation-paper.pdf
-
-
-
-
9
-
-
84860886707
-
Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC - Summary of responses to the public health consultation paper
-
European Commission
-
European Commission Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC - Summary of responses to the public health consultation paper. European Commission., http://ec.europa.eu/health/files/clinicaltrials/2010_03_30_summary_responses.pdf
-
-
-
-
10
-
-
84860889294
-
Roadmap for a legislative proposal on a Regulation/Directive amending the Clinical Trials Directive 2001/20/EC
-
European Commission
-
European Commission Roadmap for a legislative proposal on a Regulation/Directive amending the Clinical Trials Directive 2001/20/EC. European Commission., http://ec.europa.eu/governance/impact/planned_ia/docs/47_sanco_clinical_trials_directive_en.pdf
-
-
-
-
11
-
-
84860888546
-
Revision of the'Clinical Trials Directive' 2001/20/EC. Concept Paper for Public Consultation
-
European Commission
-
European Commission Revision of the'Clinical Trials Directive' 2001/20/EC. Concept Paper for Public Consultation. European Commission., http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf
-
-
-
-
12
-
-
84860887847
-
Volume 10 of Eudralex - Clinical Trials. Annex 1: Clinical Trial Application Form
-
European Commission
-
European Commission Volume 10 of Eudralex - Clinical Trials. Annex 1: Clinical Trial Application Form. European Commission., http://ec.europa.eu/health/files/eudralex/vol-10/11_an1_14-2005_en.pdf
-
-
-
-
13
-
-
77952128605
-
Global Clinical Trial Activity in the Details
-
Getz KA. Global Clinical Trial Activity in the Details. Applied Clin Trials 2007, , http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=453243&sk=&date=&pageID=3&searchString=global%20trials
-
(2007)
Applied Clin Trials
-
-
Getz, K.A.1
-
14
-
-
0028943878
-
Clinical trial initiation procedures in Europe: the legal framework and practical aspects
-
Legrand C, Cheix F, Dumais H, Laugel V, De Cremiers F, Dupont C. Clinical trial initiation procedures in Europe: the legal framework and practical aspects. Drug Inf J 1995, 29:201-259.
-
(1995)
Drug Inf J
, vol.29
, pp. 201-259
-
-
Legrand, C.1
Cheix, F.2
Dumais, H.3
Laugel, V.4
De Cremiers, F.5
Dupont, C.6
-
15
-
-
33847758747
-
Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years
-
Gluud C, Nikolova D. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. Trials 2007, 8:7.
-
(2007)
Trials
, vol.8
, pp. 7
-
-
Gluud, C.1
Nikolova, D.2
-
16
-
-
59649130335
-
Longitudinal studies and determination of risk
-
Murphy SW. Longitudinal studies and determination of risk. Methods Mol Biol 2009, 473:19-37.
-
(2009)
Methods Mol Biol
, vol.473
, pp. 19-37
-
-
Murphy, S.W.1
-
17
-
-
33644899089
-
Harmful impact of EU clinical trials directive
-
Hemminki A. Harmful impact of EU clinical trials directive. BMJ 2006, 332:501-502.
-
(2006)
BMJ
, vol.332
, pp. 501-502
-
-
Hemminki, A.1
-
19
-
-
33745157948
-
Update in methodology and conduct of clinical cancer trials
-
Therasse P, Eisenhauer EA, Buyse M. Update in methodology and conduct of clinical cancer trials. Eur J Cancer 2006, 42:1322-1330.
-
(2006)
Eur J Cancer
, vol.42
, pp. 1322-1330
-
-
Therasse, P.1
Eisenhauer, E.A.2
Buyse, M.3
-
20
-
-
33846020021
-
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
-
21
-
-
2442549008
-
European Clinical Trials Directive: the Italian position
-
Filibeck U, Addis A, Tomino C, Martini N. European Clinical Trials Directive: the Italian position. Lancet 2004, 363:1651-1652.
-
(2004)
Lancet
, vol.363
, pp. 1651-1652
-
-
Filibeck, U.1
Addis, A.2
Tomino, C.3
Martini, N.4
-
22
-
-
77955246045
-
Prescrizioni e condizioni di carattere generale, relative al l'esecuzione delle sperimentazioni cliniche dei medicinali, con particolare riferimento a quelle ai fini del miglioramento della pratica clinica, quale parte integrante dell'assistenza sanitaria
-
Unofficial English translation:, Il Ministro della Salute. Decreto Ministeriale 17 dicembre 2004
-
Il Ministro della Salute. Decreto Ministeriale 17 dicembre 2004 Prescrizioni e condizioni di carattere generale, relative al l'esecuzione delle sperimentazioni cliniche dei medicinali, con particolare riferimento a quelle ai fini del miglioramento della pratica clinica, quale parte integrante dell'assistenza sanitaria. G.U 2005, 43:26-32. Unofficial English translation: [http://ricerca-clinica.agenziafarmaco.it/sites/default/files/files_wysiwyg/files/Normativa/MD_17_december_2004_noprofit_English.pdf], Il Ministro della Salute. Decreto Ministeriale 17 dicembre 2004.
-
(2005)
G.U
, vol.43
, pp. 26-32
-
-
-
23
-
-
33845983788
-
The Clinical Trials Directive: how is it affecting Europe's non-commercial research?
-
Hartmann M, Hartmann-Vareilles F. The Clinical Trials Directive: how is it affecting Europe's non-commercial research?. PLoS Clinical Trials 2006, 1:e00013.
-
(2006)
PLoS Clinical Trials
, vol.1
-
-
Hartmann, M.1
Hartmann-Vareilles, F.2
-
24
-
-
74049103320
-
Feasibility and challenges of independent research on drugs: the Italian Medicines Agency (AIFA) experience
-
AIFA Research & Development Working Group
-
AIFA Research & Development Working Group Feasibility and challenges of independent research on drugs: the Italian Medicines Agency (AIFA) experience. Eur J Clin Invest 2010, 40:69-86. AIFA Research & Development Working Group.
-
(2010)
Eur J Clin Invest
, vol.40
, pp. 69-86
-
-
-
25
-
-
84860886623
-
Requisiti minimi per le polizze assicurative a tutela dei soggetti partecipanti alle sperimentazioni cliniche dei medicinali
-
Unofficial English translation:, Il Ministro della Salute. Decreto Ministeriale 14 Luglio 2009
-
Il Ministro della Salute. Decreto Ministeriale 14 Luglio 2009 Requisiti minimi per le polizze assicurative a tutela dei soggetti partecipanti alle sperimentazioni cliniche dei medicinali. (Unofficial English translation: [http://ricerca-clinica.agenziafarmaco.it/sites/default/files/files_wysiwyg/files/Normativa/MD_14_July_2009_English.pdf]), Il Ministro della Salute. Decreto Ministeriale 14 Luglio 2009.
-
-
-
-
26
-
-
84860889578
-
Model clinical trials agreements
-
UK Department of Health
-
UK Department of Health Model clinical trials agreements. UK Department of Health., http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/AtoZ/DH_4002073
-
-
-
-
27
-
-
54949135776
-
Regulation - the real threat to clinical research
-
Stewart P, Stears A, Tomlinson JW, Brown MB. Regulation - the real threat to clinical research. BMJ 2008, 337:1085-1087.
-
(2008)
BMJ
, vol.337
, pp. 1085-1087
-
-
Stewart, P.1
Stears, A.2
Tomlinson, J.W.3
Brown, M.B.4
-
28
-
-
78651417434
-
A new era for UK clinical research?
-
Rawlins M. A new era for UK clinical research?. Lancet 2011, 377:190-192.
-
(2011)
Lancet
, vol.377
, pp. 190-192
-
-
Rawlins, M.1
-
29
-
-
84860882262
-
EU directive threatens UK's "spectacular" record in clinical trials
-
Gulland A. EU directive threatens UK's "spectacular" record in clinical trials. BMJ 2009, 338:678.
-
(2009)
BMJ
, vol.338
, pp. 678
-
-
Gulland, A.1
-
30
-
-
84860882263
-
Germany sees rise in post-marketing studies
-
Tuffs A. Germany sees rise in post-marketing studies. BMJ 2009, 339:883.
-
(2009)
BMJ
, vol.339
, pp. 883
-
-
Tuffs, A.1
-
31
-
-
38149018609
-
Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish medicines agency, 1993-2006
-
Berendt L, Hakansson C, Bach KF, Dalhoff K, Andreasen PB, Petersen LG, Andersen E, Poulson HE. Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish medicines agency, 1993-2006. BMJ 2008, 336:33-35.
-
(2008)
BMJ
, vol.336
, pp. 33-35
-
-
Berendt, L.1
Hakansson, C.2
Bach, K.F.3
Dalhoff, K.4
Andreasen, P.B.5
Petersen, L.G.6
Andersen, E.7
Poulson, H.E.8
-
32
-
-
0842308693
-
Implementing the European clinical trials directive
-
Woods K. Implementing the European clinical trials directive. BMJ 2004, 328:240-241.
-
(2004)
BMJ
, vol.328
, pp. 240-241
-
-
Woods, K.1
-
33
-
-
48749084340
-
Globalization of sponsored clinical trials
-
Karlberg JPE. Globalization of sponsored clinical trials. Nat Rev Drug Discov 2008, 7:458-460.
-
(2008)
Nat Rev Drug Discov
, vol.7
, pp. 458-460
-
-
Karlberg, J.P.E.1
-
34
-
-
77958129704
-
Clinical trials submitted in marketing authorisation applications to the EMEA: Overview of patient recruitment and the geographical location of investigator sites
-
European Medicines Agency
-
European Medicines Agency Clinical trials submitted in marketing authorisation applications to the EMEA: Overview of patient recruitment and the geographical location of investigator sites. European Medicines Agency., http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500016819.pdf
-
-
-
-
35
-
-
84860881782
-
How to avoid further legislative fragmentation of clinical research in the European Union
-
Hartmann M, Hartmann-Vareilles F. How to avoid further legislative fragmentation of clinical research in the European Union. RAJ Pharma 2010, 21:163-168.
-
(2010)
RAJ Pharma
, vol.21
, pp. 163-168
-
-
Hartmann, M.1
Hartmann-Vareilles, F.2
-
36
-
-
61449129153
-
Challenges in the clinical development requirements for the marketing authorization of new medicines in Southeast Asia
-
Kudrin A. Challenges in the clinical development requirements for the marketing authorization of new medicines in Southeast Asia. J Clin Pharmacol 2009, 49:268-280.
-
(2009)
J Clin Pharmacol
, vol.49
, pp. 268-280
-
-
Kudrin, A.1
-
37
-
-
84860886624
-
Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology
-
University of Bonn, Faculty of Mathematics and Science
-
Hartmann M. Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology. Master thesis 2005, University of Bonn, Faculty of Mathematics and Science., http://www.dgra.de/studiengang/pdf/master_hartmann_m.pdf
-
(2005)
Master thesis
-
-
Hartmann, M.1
|