Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, Tennessee, United States of America.
PLoS Med. 2012;9(7):e1001271. doi: 10.1371/journal.pmed.1001271. Epub 2012 Jul 24.
There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities.
We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers.
Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.
在过去的 20 年中，从事美国制药业赞助的临床试验的非学术性、私营部门医生的数量急剧增加。然而，对于这些调查员在临床研究中的作用所带来的影响，研究甚少。我们的目的是研究参与美国制药临床试验的私营诊所，以了解支持药物开发的合同研究安排，特别是从事合同研究的私营部门医生如何描述他们的专业身份。
我们在 2003-2004 年进行了一项定性研究，在美国西南部的 25 个私营研究机构进行了观察，并对这些诊所的医生、研究人员和研究参与者进行了 63 次半结构化访谈。我们使用扎根理论来分析和解释我们的数据。参与我们研究的 11 名私营部门医生报告说，他们成为行业临床试验的主要研究者，主要是因为合同研究提供了额外的收入来源。这些医生报告说，他们认为自己是试验从业者和商人，而不是科学家或研究人员。
我们的研究结果表明，除了有参与合同研究的经济动机外，这些美国私营部门医生还有与基于行业的研究伦理方法相一致的专业身份。这些发现的普遍性以及它们在这几年中是否发生了变化，应该在未来的研究中加以解决。请在文章后面的“编者按”中查看。
