Mello Michelle M, Clarridge Brian R, Studdert David M
Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave., Boston, MA 02115, USA.
Account Res. 2005 Jul-Sep;12(3):163-91. doi: 10.1080/08989620500216380.
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.
我们对884名活跃于临床研究的美国医学院教员进行了邮件调查，以了解他们对行业资助的临床试验合同中那些会限制研究者学术自由并控制试验的条款的可接受性的看法。我们将他们的回答与对107所医学院研究管理人员进行的类似调查结果进行了比较。临床研究人员在可接受性判断上存在很大差异，相当大比例的临床试验研究者愿意接受给予行业赞助商对研究结果传播有相当大控制权的条款。在临床试验研究者与其他近期发表研究成果的临床研究人员的看法上；来自行业的研究支持比例高与低的研究者之间；初级教员与高级教员之间；以及国立卫生研究院（NIH）资助排名高与低的机构的研究者之间，都存在显著差异。在代表他们协商临床试验合同的临床试验人员和研究管理人员之间，在一些领域也存在重大的意见分歧。医学院教员可以从关于其机构认为行业资助的临床试验协议可接受参数的更多指导中受益。
