Effekten af GCP-direktivet pa forskerinitierede kliniske laegemiddelforsog--sekundaerpublikation

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

Effekten af GCP-direktivet pa forskerinitierede kliniske laegemiddelforsog--sekundaerpublikation

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 = "Effekten af GCP-direktivet pa forskerinitierede kliniske laegemiddelforsog--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 Udgivelsesdato: 2008/8/11",

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T1 - Effekten af GCP-direktivet pa forskerinitierede kliniske laegemiddelforsog--sekundaerpublikation

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 -