RANDOMIZED CLINICAL TRIAL 1946-1970

随机临床试验 1946-1970

• 批准号: 2032379
• 负责人: MARCIA L MELDRUM
• 金额: $ 1.65万
• 依托单位: INDIVIDUAL AWARD--MELDRUM, MARCIA L.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-01 至 1998-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2032379
• 关键词: analgesics; clinical trials; computer data analysis; contraceptives; data collection methodology /evaluation; health science research analysis /evaluation; human data; poliomyelitis vaccine; publications

DESCRIPTION (adapted from the Abstract): The goal of the proposed project is the publication of a monograph based on the Principal Investigator's doctoral dissertation at the State University of New York at Stony Brook (1994): "Departures from the design: The randomized clinical trial in historical context, 1946-1970." In this study, the Investigator employs the methods of historical and cultural analysis to examine the randomized clinical trial (RCT) as this methodology was applied to specific therapeutic problems in the 1950s and 1960s, using a case study approach. In the case studies and the analyses the Investigator addresses the production of objective knowledge from subjective evidence and the relationship between research and clinical practice; she shows that they are directly relevant to current questions regarding the evaluation of therapeutic methods and outcomes. Although the RCT is a subject of interest to physicians, health policy makers, biomedical researchers, historians, and social scientists, very little has been published on the history of this methodology. The three cases examined are the Salk polio vaccine field trials of 1954, the trials of barrier contraceptives and intrauterine contraceptive devices from the late 1950s and 1960s, and the comparative analgesics trials from the same period. These cases were selected on the bases of inherent interest, availability of archival materials, rich social context, and contemporary impact on medical practice. Research materials include medical literature, archival collections, and Food and Drug Administration records, copies of some of which were obtained under the Freedom of Information Act.

描述（根据摘要改编）：拟议项目的目标 是基于首席研究者的专着的出版 纽约州立大学Stony Brook的博士论文 （1994）：“偏离设计：随机临床试验 历史背景，1946- 1970年。“在这项研究中，研究人员采用了 历史和文化分析的方法检查随机的 临床试验（RCT），因为该方法应用于特定的治疗方法 1950年代和1960年代的问题，使用案例研究方法。 在情况下 研究和分析研究者解决了 来自主观证据的客观知识以及 研究和临床实践；她表明他们与 有关治疗方法评估的当前问题和 结果。 尽管RCT是医生感兴趣的主题，但健康 政策制定者，生物医学研究人员，历史学家和社会科学家， 关于这种方法的历史，很少发表。 所检查的三个病例是1954年的Salk脊髓灰质炎疫苗现场试验， 屏障避孕药和宫内避孕装置的试验 从1950年代后期和1960年代后期，以及来自 同一时期。 这些情况是在固有的基础上选择的 兴趣，档案材料的可用性，丰富的社会背景和 当代对医学实践的影响。 研究材料包括医学 文献，档案收藏以及食品和药物管理局记录， 其中一些的副本是根据《信息自由法》获得的。