Luleå University of Technology, 971 87 Luleå, Sweden.
Nurs Inq. 2009 Dec;16(4):347-54. doi: 10.1111/j.1440-1800.2009.00455.x.
Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.
在过去的十年中，药品临床试验的管理已经成为一个名副其实的行业，这可以从合同研究组织（CRO）的出现和扩散中得到证明，这些组织协调和监测试验。本文的重点是一家参与将新软件引入临床试验实践的 CRO 所做的工作，该软件模拟了工业生产流程。它研究了这种新的管理技术如何与在诊所进行的工作相关联，以确保试验参与者遵守方案。本文使用在“经典”管理工作和无形工作之间的分析区别，将诊所中合规的意义置于上下文中，并提出在临床试验受到私人工业管理的情况下，应该由那些关心试验有效性的人考虑产生合规性的工作。本文基于对瑞典一家大学医院的参与观察，并对护士、营养师、医生和一名软件工程师进行了访谈，他们都是参与潜在肥胖药物药物试验的团队的一部分。
