Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.
Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.
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研究人员对与行业赞助商的临床试验协议中限制性条款的可接受性的看法。
DOI：
10.1080/08989620500216380
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发表时间：
2005
期刊：
影响因子：
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通讯作者：
Studdert,DavidM
中科院分区：
文献类型：
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作者：
Mello,MichelleM;Clarridge,BrianR;Studdert,DavidM
我们对884名活跃于临床研究的美国医学院教职员工进行了一项邮件调查，以了解他们对行业赞助临床试验合同条款的可接受性的看法，这些条款将限制研究人员的学术自由和对试验的控制。我们将他们的反应与对107所医学院的研究管理人员进行的类似调查的结果进行了比较。临床研究人员在可接受性判断上存在很大差异，相对较大比例的临床试验研究人员愿意接受给予行业赞助商相当大的研究结果传播控制权的条款。临床试验研究人员与其他最近发表的临床研究人员、工业界研究支持比例高与低的研究人员、初级教师与高级教师以及国家卫生研究院(NIH)资金级别高与低的机构的研究人员的看法存在显著差异。在临床试验人员和代表他们谈判临床试验合同的研究管理人员之间，在许多领域也存在显著的观点分歧。医学院教职员工可能会受益于他们的机构认为行业赞助的临床试验协议的可接受参数的额外指导。
We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators’ academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.