TY - JOUR

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

VL - 170

SP - 2437

EP - 2439

JO - Ugeskrift for Laeger

JF - Ugeskrift for Laeger

SN - 0041-5782

IS - 33

ER -