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Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

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
OriginalsprogDansk
TidsskriftUgeskrift for Laeger
Vol/bind170
Udgave nummer33
Sider (fra-til)2437-9
Antal sider3
ISSN0041-5782
StatusUdgivet - 11 aug. 2008

ID: 120023350