Interdisziplinäres Zentrum Klinische Studien-IZKS, Universitätsmedizin der Johannes-Gutenberg-Universität Mainz.
Dtsch Arztebl Int. 2011 Sep;108(39):663-8. doi: 10.3238/arztebl.2011.0663. Epub 2011 Sep 30.
In clinical research, randomized controlled trials (RCTs) are the best way to study the safety and efficacy of new treatments. RCTs are used to answer patient-related questions and are required by governmental regulatory bodies as the basis for approval decisions.
To help readers understand and evaluate RCTs, we discuss the methods and qualitative requirements of RCTs with reference to the literature and an illustrative case study. The discussion here corresponds to expositions of the subject that can be found in many textbooks but also reflects the authors' personal experience in planning, conducting and analyzing RCTs.
The quality of an RCT depends on an appropriate study question and study design, the prevention of systematic errors, and the use of proper analytical techniques. All of these aspects must be attended to in the planning, conductance, analysis, and reporting of RCTs. RCTs must also meet ethical and legal requirements.
RCTs cannot yield reliable data unless they are planned, conducted, analyzed, and reported in ways that are methodologically sound and appropriate to the question being asked. The quality of any RCT must be critically evaluated before its relevance to patient care can be considered.
在临床研究中，随机对照试验（RCT）是研究新疗法安全性和疗效的最佳方法。RCT 用于回答与患者相关的问题，并且是政府监管机构作为批准决策基础所要求的。
为了帮助读者理解和评估 RCT，我们参考文献和一个说明性案例研究讨论了 RCT 的方法和定性要求。这里的讨论对应于许多教科书中都可以找到的主题阐述，但也反映了作者在规划、进行和分析 RCT 方面的个人经验。
RCT 的质量取决于适当的研究问题和研究设计、系统误差的预防以及适当分析技术的使用。所有这些方面都必须在 RCT 的规划、进行、分析和报告中加以关注。RCT 还必须符合伦理和法律要求。
除非 RCT 在计划、进行、分析和报告方面采用方法上合理且适合所提出问题的方式，否则它们无法产生可靠的数据。在考虑其对患者护理的相关性之前，必须对任何 RCT 的质量进行严格评估。
