Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

James D Neaton; Abdel Babiker; Mark Bohnhorst; Janet Darbyshire; Eileen Denning; Arnie Frishman; Jesper Grarup; Gregg Larson; Jens Lundgren

doi:10.1177/1740774510376547

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

James D Neaton
, Abdel Babiker
, Mark Bohnhorst
, Janet Darbyshire
, Eileen Denning
, Arnie Frishman
, Jesper Grarup
, Gregg Larson
, Jens Lundgren

30 Citations (Scopus)

Abstract

A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes of Health (NIH) have not been described.

Original language	English
Journal	Clinical trials (London, England)
Volume	7
Issue number	6
Pages (from-to)	705-18
Number of pages	14
DOIs	https://doi.org/10.1177/1740774510376547
Publication status	Published - 1 Dec 2010

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abstract = "A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes of Health (NIH) have not been described.",

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AU - Denning, Eileen

AU - Frishman, Arnie

AU - Grarup, Jesper

AU - Larson, Gregg

AU - Lundgren, Jens

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AB - A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes of Health (NIH) have not been described.

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Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

Abstract

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