Doctoral Dissertation Research Improvement:Evolving notions of objectivity: changing conceptions of what counts as clinical evidence in 20th and 21st century Russia.

这篇科学与社会博士论文研究改进基金旨在审查俄罗斯从1972年开始的30年内肿瘤学的临床研究实践。该项目将调查在此期间关于临床证据有效性的不断变化的想法，以及产生这种证据的适当方法，以及谁被批准产生这种证据。在研究俄罗斯生物医学的认识基础时，这项工作还将遵循苏联解体后这些知识基础如何经历深刻变化的过程。这一转变与苏联解体引发的俄罗斯社会经济动荡有直接关系。这项工作将分析美国和苏联研究人员在癌症化疗方面的合作项目，该项目始于1972年，是在苏联-美国医疗保健交流的赞助下进行的。对这一交换计划的档案记录的研究提供了一个极好的机会来描绘苏联和美国在临床证据的产生和评估方面的方法的差异，并对苏联的认识论进行清晰的描述。对交流计划的考察也揭示了那个时期的生物政治。该项目将采用定性研究方法，如人种学观察和俄罗斯领先肿瘤学中心的半结构化访谈，以及对已发表的科学文献的仔细审查，跟踪后苏联时期临床试验方法和数据评估标准的变化，这些变化是为了应对资金的消失、全球制药业进入俄罗斯市场以及俄罗斯政府和国际援助机构在医疗改革方面的尝试而引入的。这项研究将为各种社会科学和政策文献提供信息，通过呈现一幅关于人类受试者的癌症研究如何在随时间变化的社会背景下如何以截然不同的方式构思和实施的图景。

This Science & Society Doctoral Dissertation Research Improvement Grant seeks to examine clinical research practices in oncology in Russia over a thirty-year period beginning in 1972. The project will investigate changing ideas during this period about the validity of clinical evidence and the proper methodology for producing such evidence, as well as who is sanctioned to produce it. In researching the epistemic foundations of Russian biomedicine, this work will also follow the process of how these foundations of knowledge have undergone a profound transformation following the collapse of the Soviet Union. This transformation is directly related to the socio-economic upheavals in Russia precipitated by the collapse of the USSR. This work will analyze a cooperative project between American and Soviet researchers in cancer chemotherapy, which was conducted under the auspices of the Soviet-American healthcare exchange beginning in 1972. A study of archival records from this exchange program provides an excellent opportunity to delineate differences between Soviet and American approaches to the production and evaluation of clinical evidence, and to develop a clear picture of Soviet epistemology. An examination of the exchange program also sheds light on the biopolitics of the period. Employing qualitative research methods such as ethnographic observation and semi-structured interviews at leading Russian oncology centers, as well as careful review of published scientific literature, the project will trace the changes during the post-Soviet period in clinical trial methodology and data evaluation criteria that have been introduced in response to the disappearance of funding, the entrance of the global pharmaceutical industry into the Russian market, and the attempts at healthcare reform by the Russian government and international aid agencies. This research stands to inform a variety of social science and policy literatures, by presenting a picture of how cancer research on human subjects can be conceived and practiced quite differently in social contexts that change over time.