Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial Euro...

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Autores principales: Frewer, L J, Coles, D, van der Lans, I A, Schroeder, D, Champion, K, Apperley, J F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2011
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3252796/
https://www.ncbi.nlm.nih.gov/pubmed/20531283
http://dx.doi.org/10.1038/bmt.2010.139
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author Frewer, L J
Coles, D
van der Lans, I A
Schroeder, D
Champion, K
Apperley, J F
author_facet Frewer, L J
Coles, D
van der Lans, I A
Schroeder, D
Champion, K
Apperley, J F
author_sort Frewer, L J
collection PubMed
description The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.
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spelling pubmed-32527962012-01-10 Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT Frewer, L J Coles, D van der Lans, I A Schroeder, D Champion, K Apperley, J F Bone Marrow Transplant Original Article The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT. Nature Publishing Group 2011-03 2010-06-07 /pmc/articles/PMC3252796/ /pubmed/20531283 http://dx.doi.org/10.1038/bmt.2010.139 Text en Copyright © 2011 Macmillan Publishers Limited http://creativecommons.org/licenses/by-nc-sa/3.0/ This work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
spellingShingle Original Article
Frewer, L J
Coles, D
van der Lans, I A
Schroeder, D
Champion, K
Apperley, J F
Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT
title Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT
title_full Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT
title_fullStr Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT
title_full_unstemmed Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT
title_short Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT
title_sort impact of the european clinical trials directive on prospective academic clinical trials associated with bmt
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3252796/
https://www.ncbi.nlm.nih.gov/pubmed/20531283
http://dx.doi.org/10.1038/bmt.2010.139
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