Industry sponsorship and authorship of clinical trials over 20 years
Industry sponsorship and authorship of clinical trials over 20 years
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DOI：
10.1345/aph.1d267
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发表时间：
2004-04-01
影响因子：
2.9
通讯作者：
Jewesson, PJ
中科院分区：
文献类型：
--
作者：
Buchkowsky, SS;Jewesson, PJ
背景：制药业已成为生物医学研究的主要资金来源。我们的总体观察是，制药行业的员工越来越频繁地出现在临床试验publications.Objective的合著者：描述临床试验资金，报告和来源;调查作者与行业的关系;并描述临床结果的趋势。我们回顾了20年来发表在5种有影响力的医学期刊上的500项随机选择的临床试验结果：在回顾的500项临床试验中，181项（36%）涉及制药行业作为独立（n = 104）或联合（n = 77）申办者，180项（36%）涉及同行评审资金来源;其余的（139; 28%）没有任何声明的赞助。在1997-2000年期间，行业赞助的临床试验的百分比增加到62%。随着时间的推移，非营利组织赞助的临床试验的比例保持不变，而没有资金申报的比例则有所下降。报告的作者与行业的联系增加到66%的临床试验仅由行业赞助。在所有期刊中，观察到报告作者-行业关系的临床试验百分比增加。无论资金来源如何，大多数临床试验报告的临床结局有利于研究药物，结论：制药行业申办和混合资助的临床试验很常见，在5种综述的期刊中，这些申报资金来源的已发表试验的相对发生率有所增加。行业员工越来越频繁地作为临床试验出版物的共同作者出现。
BACKGROUND: The pharmaceutical industry has become a major source of funding for biomedical research. Our general observation is that pharmaceutical industry employees are appearing with increasing frequency as coauthors of clinical trial publications.OBJECTIVE: To characterize clinical trial funding, reporting, and sources; investigate author-industry affiliation; and describe clinical outcome trends over time.METHODS: We reviewed 500 randomly selected clinical trials published in 5 influential medical journals over a 20-year period (1981-2000).RESULTS: Of the 500 clinical trials reviewed, 181 (36%) involved pharmaceutical industry as an independent (n = 104) or joint (n 77) sponsor and 180 (36%) involved a peer-review funding source; the balance (139; 28%) lacked any declared sponsorship. The percentage of industry-sponsored clinical trials increased to 62% during 1997-2000. The percentage of nonprofit sponsored clinical trials remained constant over time, while the percentage of those without funding declaration declined. Reported author affiliation with industry increased to 66% of clinical trials sponsored only by industry. An increase in the percentage of clinical trials with reported author-industry affiliation was observed for all journals. Regardless of funding source, the majority of clinical trials reported clinical outcomes that favored the study drug,CONCLUSIONS: Pharmaceutical industry-sponsored and mixed-funding clinical trials are common, and the relative incidence of published trials with these declared funding sources in the 5 journals reviewed has increased. Industry employees are appearing as coauthors of clinical trial publications with increasing frequency.