Opinions on registering trial details: a survey of academic researchers
Opinions on registering trial details: a survey of academic researchers
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DOI：
10.1186/1472-6963-8-18
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发表时间：
2008-01-23
影响因子：
2.8
通讯作者：
Trelle, Sven
中科院分区：
文献类型：
--
作者：
Scherer, Martin;Trelle, Sven
背景资料：世界卫生组织（世卫组织）已建立了一套与研究设计和管理信息有关的项目，这些项目应构成研究登记册中的最低限度数据集。渥太华小组目前正在编制一套更全面的登记数据。由于什么都不知道学术研究人员对前瞻性研究注册的态度，我们调查了学术研究人员对他们的意见，关于注册的研究细节提出的世界卫生组织和渥太华Group.Methods：这是一个基于网络的学术研究人员目前正在运行一个制药商发起的临床研究，这是注册与clinicaltrials。2006年7月，我们通过电子邮件联系了1299名临床研究的主要研究者，解释了调查的目的，并提供了一个链接，以访问基于渥太华小组提出的最低数据集的52项问卷。每隔两周发送两封提醒邮件。采用卡方检验评估了愿意披露研究细节与研究阶段之间的相关性。为了探讨潜在的影响，无反应的偏见，我们使用逻辑回归，以评估与无反应和愿意注册study details.Results的因素之间的关联：总体反应是低的，只有282/ 1299（22%）的主要研究人员参加了调查。披露研究文件，特别是研究方案和财务协议，被认为是最有问题的，只有31%的受访者愿意公开披露这些文件。因此，在282个国家中，只有34个国家（12%）同意披露渥太华小组提议的所有细节。Logistic回归分析表明，无应答者和愿意透露details.Conclusion的特点之间没有关联：非行业赞助的研究的主要研究者不愿意透露所有的数据项目提出的渥太华集团。披露研究方案和财务协议被认为是最有问题的。关于试验注册的未来讨论不仅应关注工业界，还应关注学术研究人员。
Background: The World Health Organization ( WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group.Methods: This was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials. gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details.Results: Overall response was low as only 282/ 1299 ( 22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 ( 12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details.Conclusion: Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers.