Nelson Nicole C, Keating Peter, Cambrosio Alberto, Aguilar-Mahecha Adriana, Basik Mark
Department of the History of Science, University of Wisconsin-Madison, 1225 Linden Drive, Madison, WI 53706, USA.
Department of History, Université du Québec à Montréal, Pavillon Lionel-Groulx, 3150 Jean-Brillant, Montréal, Quebec H3T 1N, Canada.
Soc Sci Med. 2014 Jun;111:74-83. doi: 10.1016/j.socscimed.2014.04.008. Epub 2014 Apr 12.
Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible to mere drug testing. Drawing on ethnographic fieldwork and interviews with researchers in the field of oncology from 2010 to 2013, we introduce a conceptual contrast between trials as testing machines and trials as clinical experimental systems to draw attention to the ways trials are increasingly being used to ask open-ended scientific questions. When viewed as testing machines, clinical trials are seen as a means to produce answers to straightforward questions and deviations from the protocol are seen as bugs in the system; but practitioners can also treat trials as clinical experimental systems to investigate as yet undefined problems and where heterogeneity becomes a means to produce novel biological or clinical insights. The rise of "biomarker-driven" clinical trials in oncology, which link measurable biological characteristics such as genetic mutations to clinical features such as a patient's response to a particular drug, exemplifies a trend towards more experimental styles of clinical work. These transformations are congruent with changes in the institutional structure of clinical research in oncology, including a movement towards more flexible, networked research arrangements, and towards using individual patients as model systems for asking biological questions.
临床试验通常被描述为用于生成有关药物安全性和有效性的特定信息的类似机器的系统，并被理解为工业药物开发过程的一个组成部分。本文认为，当代肿瘤学临床试验不能简单地归结为单纯的药物测试。基于2010年至2013年的人种志田野调查以及对肿瘤学领域研究人员的访谈，我们引入了作为测试机器的试验和作为临床实验系统的试验之间的概念对比，以提请注意试验越来越多地被用于提出开放式科学问题的方式。当被视为测试机器时，临床试验被视为产生直接问题答案的一种手段，而与方案的偏差则被视为系统中的漏洞；但从业者也可以将试验视为临床实验系统，以研究尚未明确的问题，在这种情况下，异质性成为产生新的生物学或临床见解的一种手段。肿瘤学中“生物标志物驱动”的临床试验的兴起，将可测量的生物学特征（如基因突变）与临床特征（如患者对特定药物的反应）联系起来，体现了临床工作向更具实验性风格发展的趋势。这些转变与肿瘤学临床研究机构结构的变化相一致，包括朝着更灵活、网络化的研究安排发展的趋势，以及将个体患者用作提出生物学问题的模型系统的趋势。
