Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation

Louise Berendt; Cecilia Håkansson; Karin Friis Bach; Kim Dalhoff; Per Buch Andreasen; Lene Birgitte Grejs Petersen; Elin Andersen; Henrik Enghusen Poulsen

Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation

Translated title of the contribution: [Effect of the GCP Directive on academic drug trials]

Louise Berendt, Cecilia Håkansson, Karin Friis Bach, Kim Dalhoff, Per Buch Andreasen, Lene Birgitte Grejs Petersen, Elin Andersen, Henrik Enghusen Poulsen

Abstract

Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies.

Translated title of the contribution	[Effect of the GCP Directive on academic drug trials]
Original language	Danish
Journal	Ugeskrift for Laeger
Volume	170
Issue number	33
Pages (from-to)	2437-9
Number of pages	3
ISSN	0041-5782
Publication status	Published - 11 Aug 2008

Cite this

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title = "Effekten af GCP-direktivet p{\aa} forskerinitierede kliniske laegemiddelfors{\o}g--sekundaerpublikation",

abstract = "Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies.",

author = "Louise Berendt and Cecilia H{\aa}kansson and Bach, {Karin Friis} and Kim Dalhoff and Andreasen, {Per Buch} and Petersen, {Lene Birgitte Grejs} and Elin Andersen and Poulsen, {Henrik Enghusen}",

year = "2008",

month = aug,

day = "11",

language = "Dansk",

volume = "170",

pages = "2437--9",

journal = "Ugeskrift for Laeger",

issn = "0041-5782",

publisher = "Almindelige Danske Laegeforening",

number = "33",

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TY - JOUR

T1 - Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation

AU - Berendt, Louise

AU - Håkansson, Cecilia

AU - Bach, Karin Friis

AU - Dalhoff, Kim

AU - Andreasen, Per Buch

AU - Petersen, Lene Birgitte Grejs

AU - Andersen, Elin

AU - Poulsen, Henrik Enghusen

PY - 2008/8/11

Y1 - 2008/8/11

N2 - Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies.

AB - Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies.

M3 - Tidsskriftartikel

SN - 0041-5782

VL - 170

SP - 2437

EP - 2439

JO - Ugeskrift for Laeger

JF - Ugeskrift for Laeger

IS - 33

ER -

Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation

Abstract

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