HISTORY OF THE RANDOMIZED CLINICAL TRIAL, 1946-1969

随机临床试验的历史，1946 年至 1969 年

• 批准号: 3427492
• 负责人: MARCIA L MELDRUM
• 金额: $ 2万
• 依托单位: INDIVIDUAL AWARD--MELDRUM, MARCIA L.
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-09-01 至 1991-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3427492
• 关键词: clinical trials; health science research analysis /evaluation; history of life science

The planned project will ask the question, what was the historical process by which the conventions of the randomized clinical trial (RCT) were developed into a fully defined methodology and accepted by U.S. policy makers and the American scientific community as the "gold standard" for the evaluation of the effectiveness of medical products and procedures? There are two phases of the project: first, an investigation of the internal process by which the FDA gave the RCT official regulatory status in 1969; secondly, a review of carefully selected specific trials of the 1950s and 1960s and the negotiation process which framed their planning and implementation. The hypothesis of the study is that the RCT is not a static dogma, but a dynamic tool, which was crafted and adapted for use in a specific American historical context, and has been further modified and redesigned to meet changing medical and social needs within its history. This reconsideration of the RCT should offer productive insights into its future application as a measure of medical effectiveness.

计划的项目将问这个问题，历史过程是什么 随机临床试验（RCT）的惯例为 发展为完全定义的方法，并被美国政策所接受 制造商和美国科学界作为“黄金标准” 评估医疗产品和程序的有效性？ 那里 是该项目的两个阶段：首先，对内部的调查 FDA在1969年赋予RCT官方监管状况的过程； 其次，对1950年代精心选择的特定试验的审查以及 1960年代和谈判过程，构成了他们的计划和 执行。 该研究的假设是RCT不是静态教条，而是 动态工具，该工具是在特定的美国人 历史背景，并经过了进一步的修改和重新设计以满足 改变其历史上的医疗和社会需求。这种重新考虑 RCT中应提供对未来应用的富有成效的见解 衡量医疗有效性的方法。