How conducting a clinical trial affects physicians' guideline adherence and drug preferences
How conducting a clinical trial affects physicians' guideline adherence and drug preferences
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DOI：
10.1001/jama.295.23.2759
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发表时间：
2006-06-21
影响因子：
120.7
通讯作者：
Sondergaard, Jens
中科院分区：
文献类型：
--
作者：
Andersen, Morten;Kragstrup, Jakob;Sondergaard, Jens
背景全科医生经常参与由制药公司赞助的临床试验，但参与对他们的处方模式的影响尚未被评估。目的确定公司赞助的临床试验如何影响医生遵守国际治疗建议和他们对制药公司药物的处方。丹麦富嫩县的设计、设置和患者观察性队列研究，将10种进行哮喘药物试验的做法与165种对照(非试验进行)做法进行比较。研究人群包括来自试验指导实践的5439名接受哮喘药物治疗的患者和来自对照实践的59574名患者。Practice在2001年4月26日至2002年10月7日期间进行了这项试验。主要结果衡量哮喘患者对吸入性皮质类固醇使用指南的遵守程度。结果哮喘患者使用吸入性糖皮质激素的比例在试验实施时为68.5%，在对照试验中为69.1%。进行试验并不影响指南的依从性(两年后的优势比[OR]为1.00；95%可信区间[CI]为0.84-1.19)。在试验实践中，赞助公司在哮喘药物处方总量中的份额比对照实践有所增加(6.7%；95%可信区间，3.0%-11.7%)。这可能归因于对该公司吸入性皮质类固醇的显著偏好(OR，1.26；95%CI，1.04-1.54)以及该公司其他哮喘药物的处方增加的趋势。结论由制药公司赞助的试验对医生遵守国际治疗建议没有显著影响，但增加了他们对试验赞助者药物的使用。
Context 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.Design, Setting, and Patients 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.Main Outcome Measures 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.Conclusion 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.