Project ImpACT:Important Achievements of Clinical Trial

项目影响：临床试验重要成果

• 批准号: 6599525
• 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 2006-06-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6599525
• 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）：拟议活动的目的将是开发一本书，以自1948年第一个大型医学大型RCT的年份（英国链霉菌素试验）自1948年以来，最重要的随机临床试验（RCT）在医学和公共卫生的所有领域中对所有医学和公共卫生的所有领域的影响。令人惊讶的是，尽管RCT在医学实践中具有公认的重要性，但目前尚无此类资料。这将是一本经过编辑的书，将是组织努力的主要产品，称为项目影响（临床试验的重要成就）。该项目将涉及一系列临床研究人员，专家和（所有医学领域的知识渊博的方法论专家）。 我们非常广泛地定义“影响”，为： 1.）对医学或公共卫生实践的影响（例如，根据RCT开始或停止治疗或实践。） 2.）对设计，进行或分析试验方法的影响。 （例如，刺激对数据监视板的需求的识别） 3）。影响随后的研究过程。 4.）对理解病理生理学和生物学的影响。 5.）对法规，法律或政策的影响 5.）对道德理解和试验的行为的影响 除了报告包括试验的设计和发现外，本书还将尝试描述在已发表的审判报告中通常找不到的内容；在报告审判之前，知识或实践的状态，开发审判的政治和科学环境，研究人员认为的各种设计选择以及可能已经进行的各种战斗以旨在进行试验的设计，其原因是先前试验可能没有的影响以及对试验或结果的直接和长期反应的影响。这些信息将从参与的调查人员或其他，社论，教科书和历史学家，学者和记者的账户中收集有关该审判的辅助文章。在可能的情况下，该领域的专家，调查人员本身以及在审判期间活跃的科学家的信息将在可能的情况下进行增强。 最终的目标是从这些试验中学习，以一种将与斗争和艰难的问题相关的教训，并对临床医生，医学研究人员，方法论学家和政策制定者提供信息和有趣的内容。