Project ImpACT:Important Achievements of Clinical Trial

项目影响：临床试验重要成果

• 批准号: 6932111
• 负责人: Steven N. Goodman
• 金额: $ 8.18万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-15 至 2006-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6932111
• 关键词: books; clinical research; clinical trials; ethics; experimental designs; health care policy; health science research analysis /evaluation; history of life science; literature survey; public health

DESCRIPTION (provided by applicant): The aim of the proposed activity will be to develop a book that selects, describes, and documents the impact of the most important randomized clinical trials (RCTs) in all areas of medicine and public health since 1948, the year of the first large-scale RCT in medicine, the British Streptomycin trial. Surprisingly, in spite of the recognized importance of RCTs for the practice of medicine, no such source currently exists. This will be an edited book, and will be the main product of an organizational effort called Project ImpACT (Important achievements of Clinical Trials). This project will involve a range of clinical researchers, specialists, and (knowledgeable methodological experts from all domains of medicine. We are defining "impact" very broadly, as: 1.) Impact on the practice of medicine or public health (e.g. therapies or practices started or stopped on the basis of an RCT.) 2.) Impact on methods of designing, conducting or analyzing trials. (e.g. stimulating recognition of the need for data monitoring boards) 3). Impact on the subsequent course of research. 4.) Impact on the understanding of pathophysiology and biology. 5.) Impact on regulations, law or policy 5.) Impact on ethical understanding and conduct of trials In addition to reporting the design and findings of the included trials, this book will attempt to describe what cannot typically be found in published trial reports; the state of knowledge or practice before the trial was reported, the political and scientific context in which the trial was developed, the various design choices that the investigators considered and the battles that may have been fought to get the trial designed the way it was, the reasons it had an impact where previous trials may not have, and the nature of the immediate and longer term reactions to the trial conduct or results. This information will be gathered from ancillary articles written about the trial by either the participating investigators or others, editorials, textbooks, and accounts of historians, scholars and journalists. This will be augmented where possible by information from specialists in the field, from the investigators themselves, and from scientists who were active during the time of the trial. The ultimate goal will be to learn from these trials in a way that will teach us lessons that are relevant to present struggles and tough questions, and be informative and interesting to clinicians, medical researchers, methodologists and policy makers.

描述（由申请人提供）：拟议活动的目的是编写一本书，选择，描述和记录自1948年以来医学和公共卫生所有领域最重要的随机临床试验（RCT）的影响，这是第一个大规模RCT的医学，英国链霉素试验。令人惊讶的是，尽管公认的重要性随机对照试验的医学实践，没有这样的来源目前存在。这将是一本编辑过的书，也将是一个名为“临床试验的重要成就”（Project ImpACT）的组织努力的主要成果。该项目将涉及一系列的临床研究人员，专家，和（知识渊博的方法学专家从医学的所有领域。 我们对“影响”的定义非常广泛，如： 1.）的人。对医学实践或公共卫生的影响（例如，基于RCT开始或停止的治疗或实践。） 2.）的情况。对试验设计、实施或分析方法的影响。(e.g.促使人们认识到需要设立数据监测委员会） 3）。对后续研究进程的影响。 4.）对病理生理学和生物学理解的影响。 5.）对法规、法律或政策的影响 5.）对伦理理解和试验进行的影响 除了报告试验的设计和发现，这本书将试图描述什么不能典型地在出版的试验报告中发现;报告审判前的知识或实践状况，审判开展的政治和科学背景，调查人员所考虑的各种设计选择，以及为使试验按原来的方式设计而可能进行的斗争，它产生以前试验可能没有的影响的原因，以及对试验进行或结果的直接和长期反应的性质。这些信息将从参与研究者或其他人撰写的关于试验的辅助文章、社论、教科书以及历史学家、学者和记者的叙述中收集。在可能的情况下，这将通过来自该领域专家、研究者本人和在试验期间活跃的科学家的信息来补充。 最终的目标是从这些试验中学习，使我们能够学到与目前的斗争和坚韧问题相关的教训，并为临床医生、医学研究人员、方法学家和政策制定者提供信息和有趣的东西。

项目成果

The Salk Polio Vaccine Trial of 1954: risks, randomization and public involvement in research.

1954 年索尔克脊髓灰质炎疫苗试验：风险、随机化和公众参与研究。

• DOI: 10.1191/1740774504cn010xx
• 发表时间: 2004
• 期刊: Clinical trials (London, England)
• 作者: Dawson,Liza