Department of Health Care Policy, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
J Clin Oncol. 2010 Mar 10;28(8):1316-21. doi: 10.1200/JCO.2008.21.6606. Epub 2010 Jan 11.
PURPOSE To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. METHODS Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included sponsorship, age group (adult v pediatric), phase, single versus multicenter, country (United States v other), and number of authors. Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing). Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models. Results One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001). The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship. CONCLUSION Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry.
检验这样一个假设,即在肿瘤学临床试验中扮演关键科学角色的作者,因此对试验的设计、分析、解释或报告具有更大的影响力,他们比那些不扮演此类角色的作者更有可能与行业有财务联系。
从 2006 年 1 月 1 日至 2007 年 6 月 30 日发表在《临床肿瘤学杂志》上的所有药物或生物制剂临床试验(n=235)中提取数据。文章层面的数据包括赞助、年龄组(成人与儿科)、阶段、单中心与多中心、国家(美国与其他国家)和作者人数。作者层面的数据(n=2927)包括财务关系(如雇佣、咨询)和关键科学角色的履行情况(即构思/设计、分析/解释或手稿撰写)。使用广义线性混合模型,在调整文章层面的协变量后,检验履行关键角色与财务关系之间的关联。
1881 名作者(64%)报告至少履行了一个关键角色,842 名作者(29%)报告至少有一个财务关系。与其他作者相比,报告履行关键角色的作者更有可能与行业有财务联系(调整后的优势比[OR],4.3;99%可信区间[CI],3.0 至 6.0;P<0.0001)。在有行业资助的试验中,这种关联比没有行业资助的试验更强(OR,5.0[99%CI,3.4 至 7.5]比 OR,2.5[99%CI,1.3 至 4.8]),但无论赞助情况如何,这种关联都存在。
在肿瘤学临床试验的构思和设计、分析、解释或报告中扮演关键角色的作者,比那些不扮演此类角色的作者更有可能与行业有财务联系。