How conducting a clinical trial affects physicians' guideline adherence and drug preferences.
BACKGROUND
General practitioners are frequently involved in clinical trials sponsored by pharmaceutical companies but the effects of participation on their prescribing patterns have not been evaluated.


OBJECTIVE
To determine how conducting a company-sponsored clinical trial influenced physicians' adherence to international treatment recommendations and their prescribing of the pharmaceutical company's drugs.


METHODS
Observational cohort study in Funen County, Denmark, comparing 10 practices that were conducting a trial on asthma medicine with 165 control (non-trial-conducting) practices. The study population included 5439 patients treated with asthma drugs from the trial-conducting practices and 59,574 patients from the control practices. Practices conducted the trial between April 26, 2001, and October 7, 2002.


METHODS
Adherence to guidelines measured as use of inhaled corticosteroids among asthma patients. Prevalence of use of the company's drugs and the trial sponsor's share of the total volume of asthma drugs prescribed.


RESULTS
The baseline proportion of asthma patients using inhaled corticosteroids was 68.5% in trial-conducting and 69.1% in control practices. Conducting the trial did not influence guideline adherence (odds ratio [OR] after 2 years, 1.00; 95% confidence interval [CI], 0.84-1.19). In trial-conducting practices, the sponsoring company's share of the total prescribed volume of asthma drugs increased compared with control practices (6.7%; 95% CI, 3.0%-11.7%). This could be attributed to a significantly higher preference for the company's inhaled corticosteroids (OR, 1.26; 95% CI, 1.04-1.54) and trends toward increased prescribing of the company's other asthma drugs.


CONCLUSIONS
Conducting a trial sponsored by a pharmaceutical company had no significant impact on physicians' adherence to international treatment recommendations but increased their use of the trial sponsor's drugs.
Andersen
Morten
M
Research Unit for General Practice, University of Southern Denmark, Odense, Denmark. mandersen@health.sdu.dk
Kragstrup
Jakob
J
Søndergaard
Jens
J
D018927:Anti-Asthmatic Agents / Q000145:classification / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D003718:Denmark; D004345:Drug Industry; D011307:Drug Prescriptions / Q000145:classification; D005194:Family Practice / Q000706:statistics & numerical data*; D005938:Glucocorticoids / Q000145:classification / Q000627:therapeutic use; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012109:Research Support as Topic
D018927:Anti-Asthmatic Agents; D005938:Glucocorticoids