临床试验(Ⅰ)

Clinical Trials (PartⅠ)

我们已经进入医学发展速度空前的新时代，新知识、新疗法、新的诊断工具与程序、新的预防措施层出不穷．这是由于科学的研究方法和传统的医学方法相结合而形成的．涉及人体的临床试验不仅因素复杂，而且常常面临伦理问题；但任何一种医学上的进展，最后都难免至少是部份地要依靠临床试验来证实． 本文的主要目的是向从事应用统计的读者介绍“临床试验”（ｃｌｉｎｉｃａｌ Ｔｒｉａｌｓ）的地位与内涵；医学研究中的偏性；将试验设计与统计分析的基本原则与方法应用于临床医学研究遇到的问题、机会、进展和困难．具体内容分两篇．本篇包括：１，引言；２，医学研究中的偏性；３，伦理问题；４，试验设计，包括对传统方法的讨论、序贯平衡、不同阶段（Ｐｈｓｅ）相结合．下篇包括生存质量分析；依从性和Ｍｅｔａ分析等．

This entensive review on clinical trials for applied statistictians is intended to outline the problems in the application of statistical principles and methods to clinical research, biases in medical research, and the challenges progress, prospects and difficulties of clinical trials. The prominent place occupied by clinical trials is stressed. The first part of the paper consists of (1) introduction, (2) biases in clinical research, (3) ethical issues, (4) the design for clinical trials, its subconsisting of crossover designs, sequential treatment assignment, and phase combination design. The part II will focus on the analytic aspects of clinical trials.