[Clinical trials in Norway--completion and reporting are not satisfactory].
OBJECTIVE
To investigate how drug trials are carried out and reported in Norway and to what extent they are published.


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%).


CONCLUSIONS
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.
Sandaker
Linda
L
Institutt for farmakoterapi, Det medisinske fakultet, Universitetet i Oslo, Postboks 1065 Blindern ,0316 Oslo.
Fjeld
Bente
B
Reikvam
Asmund
A
Lislevand
Harald
H
Madsen
Steinar
S
D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards / Q000706:statistics & numerical data; D004345:Drug Industry / Q000191:economics; D006801:Humans; D015337:Multicenter Studies as Topic / Q000191:economics / Q000592:standards / Q000706:statistics & numerical data; D009664:Norway; D011643:Publishing / Q000592:standards / Q000706:statistics & numerical data; D012109:Research Support as Topic / Q000191:economics