An analysis of the clinical development of drugs in Norway for the years 2000 and 2004: the influence of the pharmaceutical industry.
OBJECTIVE
Little has been published either concerning the total number of research projects in connection with clinical development of drugs or the number of projects financially supported by the industry.


METHODS
From the archives of the five regional Norwegian Research Ethical Committees (REC), all research projects in connection with clinical development of drugs for the years 2000 and 2004 were analysed with the intention of finding the number of projects financially supported by the industry, the type of research institution, the industrial company, the topic of the research as classified in the international Anatomic Therapeutic Classification system (ATC), the research phase and the approval status of the drug by the Norwegian Medicines Agency (NMA).


RESULTS
The total number of research projects for the clinical development of drugs for the years 2000 and 2004 was 489, and 75.7% were financially supported by the industry. More than two-thirds of the projects were done in academic institutions and about one-third were equally divided between public health hospitals and private health service/hospitals. Eight of the 88 drug companies involved were among the world's largest and supported 38% of the projects. Fifty-nine percent of all the projects were within four therapeutic groups: antineoplastic/immunomodulating agents, nervous system, cardiovascular system and alimentary tract/metabolism. The distribution of research phases was as follows: phase I 1.2%, phase II 16.4%, phase III 26.6% and phase IV 55.8%. In the phase IV drug trials, drugs had been approved for sale by the NMA.


CONCLUSIONS
The share of research projects related to the development of drugs supported by the industry is high. Research independent of the industry is of importance to avoid bias and selective publications and to prevent research as a means of marketing. Independent research should be encouraged and financially supported by sources with no connection to the drug industry.
Winther
Finn O
FO
Faculty Division Rikshospitalet, University of Oslo, 0027, Oslo, Norway. finnow@ulrik.uio.no
Hole
Ola P
OP
Nitter-Hauge
Sigurd
S
D000047:Academies and Institutes / Q000191:economics / Q000706:statistics & numerical data; D015982:Bias; D035843:Biomedical Research / Q000191:economics* / Q000941:ethics / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000191:economics* / Q000941:ethics / Q000706:statistics & numerical data; D016265:Conflict of Interest; D004345:Drug Industry / Q000191:economics* / Q000941:ethics / Q000706:statistics & numerical data; D016304:Hospitals, Private / Q000191:economics / Q000706:statistics & numerical data; D006779:Hospitals, Public / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D009664:Norway / Q000453:epidemiology; D012109:Research Support as Topic / Q000941:ethics / Q000706:statistics & numerical data*; D013997:Time Factors