[Effect of the GCP Directive on academic drug trials]
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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[Effect of the GCP Directive on academic drug trials]. / Berendt, L.; Hakansson, C.; Bach, K.F.; Dalhoff, K.; Andreasen, P.B.; Petersen, L.G.; Andersen, E.; Poulsen, H.E.
I: Ugeskrift for læger, Bind 170, Nr. 33, 2008, s. 2437-2439.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
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
VL - 170
SP - 2437
EP - 2439
JO - Ugeskrift for Laeger
JF - Ugeskrift for Laeger
SN - 0041-5782
IS - 33
ER -
ID: 10902049