[Effect of the GCP Directive on academic drug trials]

L. Berendt; C. Hakansson; K.F. Bach; K. Dalhoff; P.B. Andreasen; L.G. Petersen; E. Andersen; H.E. Poulsen

[Effect of the GCP Directive on academic drug trials]

L. Berendt, C. Hakansson, K.F. Bach, K. Dalhoff, P.B. Andreasen, L.G. Petersen, E. Andersen, H.E. 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
Udgivelsesdato: 2008/8/11

Original language	Danish
Journal	Ugeskrift for læger
Volume	170
Issue number	33
Pages (from-to)	2437-2439
Number of pages	2
ISSN	0041-5782
Publication status	Published - 2008

Cite this

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title = "[Effect of the GCP Directive on academic drug trials]",

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 Udgivelsesdato: 2008/8/11",

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T1 - [Effect of the GCP Directive on academic drug trials]

AU - Berendt, L.

AU - Hakansson, C.

AU - Bach, K.F.

AU - Dalhoff, K.

AU - Andreasen, P.B.

AU - Petersen, L.G.

AU - Andersen, E.

AU - Poulsen, H.E.

PY - 2008

Y1 - 2008

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 Udgivelsesdato: 2008/8/11

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 Udgivelsesdato: 2008/8/11

M3 - Tidsskriftartikel

SN - 0041-5782

VL - 170

SP - 2437

EP - 2439

JO - Ugeskrift for Laeger

JF - Ugeskrift for Laeger

IS - 33

ER -