The geographical distribution of leadership in globalized clinical trials.
The geographical distribution of leadership in globalized clinical trials.
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DOI：
10.1371/journal.pone.0045984
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Heerspink HL
中科院分区：
文献类型：
--
作者：
Hoekman J;Frenken K;de Zeeuw D;Heerspink HL
药物试验主要由美国、西欧和日本的赞助商和研究人员发起。然而，越来越多的患者在中东欧、拉丁美洲和亚洲登记。患者在新的地理环境中的参与引发了对科学和道德完整性的质疑，特别是在试验管理层面缺乏与这些环境相关的经验的情况下。因此，我们研究了在试验管理团队的组成中，患者登记的地理位置变化在多大程度上被预期，使用主要结果出版物上的作者国籍作为领导力的指标。我们在www.Clinicaltrials.gov上的1,445项注册试验中进行了一项队列研究，该研究可以使用出版物中列出的临床试验注册编号与初步结果出版物相匹配。从所有登记中摘录了赞助商和招生国家的名称。从出版物中摘录了所有作者的作者地址。我们搜索了所有出版物的作者地址，以确定登记上列出的注册国家和赞助商是否也出现在匹配的出版物上。在所有赞助商中，80.1%的人在出版物上列出了作者地址。在所有注册国家中，50.3%的国家在出版物上提供了作者地址。与政府资助(90.4%)和非营利性资助(93.7%)相比，行业资助试验的登记国家名单特别低(39.9%)。我们发现，与波兰(27.3%)和墨西哥(14.1%)等非传统研究地点相比，美国(98.2%)和日本(72.0%)等传统研究地点在行业资助试验中登记的国家/地区更多。尽管进行了患者登记工作，但以他们对手稿写作的贡献来衡量，来自非传统地点的研究人员参与试验管理的程度并不高。这种分工对全球临床研究的科学和伦理完整性具有重要影响。
Pharmaceutical trials are mainly initiated by sponsors and investigators in the United States, Western Europe and Japan. However, more and more patients are enrolled in Central and Eastern Europe, Latin America and Asia. The involvement of patients in new geographical settings raises questions about scientific and ethical integrity, especially when experience with those settings is lacking at the level of trial management. We therefore studied to what extent the geographical shift in patient enrolment is anticipated in the composition of trial management teams using the author nationalities on the primary outcome publication as an indicator of leadership. We conducted a cohort-study among 1,445 registered trials in www.clinicaltrials.gov that could be matched with a primary outcome publication using clinical trial registry numbers listed in publications. The name of the sponsor and the enrolment countries were extracted from all registrations. The author-addresses of all authors were extracted from the publications. We searched the author-address of all publications to determine whether enrolment countries and sponsors listed on registrations also appeared on a matched publication. Of all sponsors, 80.1% were listed with an author-address on the publication. Of all enrolment countries, 50.3% appeared with an author-address on the publication. The listing of enrolment countries was especially low for industry-funded trials (39.9%) as compared to government (90.4%) and not-for-profit funding (93.7%). We found that listing of enrolment countries in industry-funded trials was higher for traditional research locations such as the United States (98.2%) and Japan (72.0%) as compared to nontraditional research locations such as Poland (27.3%) and Mexico (14.1%). Despite patient enrolment efforts, the involvement of researchers from nontraditional locations in trial management as measured by their contribution to manuscript writing is modest. This division of labor has significant implications for the scientific and ethical integrity of global clinical research.
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DOI：
10.1146/annurev.soc.34.040507.134743
发表时间：
2010-01-01
期刊：
ANNUAL REVIEW OF SOCIOLOGY, VOL 36
影响因子：
--
作者：
Rivera, Mark T.;Soderstrom, Sara B.;Uzzi, Brian
通讯作者：
Uzzi, Brian
影响因子：
2.2
作者：
Abbas, E. E.
通讯作者：
Abbas, E. E.
影响因子：
4.4
作者：
GRANOVETTER, M
通讯作者：
GRANOVETTER, M
影响因子：
5.3
作者：
Olson, GM;Olson, JS
通讯作者：
Olson, JS
影响因子：
4.6
作者：
Boschma, RA
通讯作者：
Boschma, RA