Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation. / Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Petersen, Lene Birgitte Grejs; Andersen, Elin; Poulsen, Henrik Enghusen.
In: Ugeskrift for Laeger, Vol. 170, No. 33, 11.08.2008, p. 2437-9.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
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
VL - 170
SP - 2437
EP - 2439
JO - Ugeskrift for Laeger
JF - Ugeskrift for Laeger
SN - 0041-5782
IS - 33
ER -
ID: 34090805