Project ImpACT:Important Achievements of Clinical Trial

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年以来最重要的随机临床试验(RCT)在所有医学和公共卫生领域的影响，1948年是第一次大规模医学随机临床试验--英国链霉素试验的年份。令人惊讶的是，尽管随机对照试验对医学实践的重要性得到了承认，但目前并不存在这样的来源。这将是一本经过编辑的书，将是一个名为Project Impact(临床试验的重要成果)的组织努力的主要成果。这个项目将涉及来自医学各个领域的一系列临床研究人员、专家和知识渊博的方法学专家。 我们对“影响”的定义非常宽泛，包括： 1)对医学或公共卫生实践的影响(例如，根据随机对照试验开始或停止的治疗或实践)。 2.)对设计、进行或分析试验的方法的影响。(例如，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的理解产生了影响。 5.)对法规、法律或政策的影响 5.)对审判的道德理解和进行的影响 除了报告纳入试验的设计和结果外，这本书还将试图描述在已发表的试验报告中通常找不到的东西；在报告试验之前的知识或实践状态；试验是在何种政治和科学背景下进行的；调查人员考虑的各种设计选择和为使试验设计成原来的方式而可能进行的战斗；它产生影响的原因，以前的试验可能没有的影响；以及对试验进行或结果的直接和长期反应的性质。这些信息将从参与调查人员或其他人撰写的关于审判的辅助文章、社论、教科书以及历史学家、学者和记者的描述中收集。在可能的情况下，将通过来自该领域专家、调查人员本身以及在试验期间活跃的科学家提供的信息来加强这一点。最终目标将是以一种方式从这些试验中吸取教训，这些教训将与当前的斗争和棘手问题相关，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信息。

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.