Klinisk legemiddelutprövning i Norge - gjennomföring og rapportering er ikke tilfredsstillende
Engelsk titel: Clinical trials in Norway - completion and reporting are not satisfactory
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Författare:
Sandaker L
;
Fjeld B
;
Reikvam Å
;
Lislevand H
;
Madsen S
Email: asmund.reikvam@medisin.uio.no
Språk: Nor
Antal referenser: 9
Dokumenttyp:
Artikel
UI-nummer: 04111575
Sammanfattning
OBJECTIVE : To investigate how drug trials are carried out and reported in Norway and to what extent they are published.
MATERIAL AND METHODS : All drug trials notified in 1996 were included in the study. Data were obtained from the standard notification form, correspondence with investigators, end-of-study reports, and a questionnaire designed for this study.
RESULTS : A total of 208 drug trials were notified. Most trials were initiated by the pharmaceutical industry (85%) and international multicenter studies constituted a major part (73%). Mandatory end-of-study reports were submitted to the health authorities on 48 (23%) of the trials. Out of a total of 159 trials for which we have data, 39 (25%) were interrupted or not started. Out of a total of 143 trials for which we have data on publishing, 77 (54%) were not published. Trials with a positive conclusion (54%) were more likely to be published than those with a negative conclusion (38%).
INTERPRETATION : The reporting of drug trials is not satisfactory. Because of low reporting frequency, health authorities do not obtain a comprehensive overview. The pharmaceutical industry initiates the majority of the trials and clinical researchers in Norway increasingly participate in international multicentre trials. Many trials are not carried out as planned; less than half are published.